Medical devices
10 FDA PMA submissions experts
These ten regulatory affairs professionals have prepared and managed FDA premarket approval (PMA) submissions and supplements for medical devices. A reader can learn how device companies plan, prepare and maintain PMA filings with FDA.
Professionals to explore
01—10Amarilys Machado, MBA MT(ASCP)
LinkedInExperience: Senior Regulatory Affairs Manager · Codman & Shurtleff Inc., a Johnson & Johnson Company
Senior Regulatory Affairs Manager at Codman & Shurtleff Inc., a Johnson & Johnson Company since 2011. The profile describes managing the Regulatory Affairs Department at Codman Neurovascular, covering submission, approval, registration and licensing of Class II and Class III devices, including preparation of 510ks, PMAs, IDEs and HDE Supplements. Other listed roles include Regulatory Affairs Manager at Johnson & Johnson (2009–2011) and Manager, Regulatory Affairs at Cordis (2005–2008).
Ankita Phophalia, MS, RAC
LinkedInExperience: Director of Regulatory Affairs · Cordis
Director of Regulatory Affairs at Cordis since May 2026; the listing also shows Sr. Regulatory Affairs Manager (2022–2026) and Regulatory Affairs Manager (2017–2022) at Cordis. The profile describes preparing and submitting PMA supplements (30-day notice, Special Supplement and RTR) and IDE supplements to FDA for a Class III active implantable device, and supporting the filing of the final PMA module containing clinical information for a class III combination product.
Aruna Akkapeddi
LinkedInExperience: Director of Regulatory Affairs · Recor Medical
Former Director of Regulatory Affairs at Recor Medical (2020–2025) and Senior Director Regulatory Affairs there in 2025; the listing also shows Vice President of RA and QA at May Health (2025–2026). The profile describes serving as product lead for multiple PMA devices supporting endovascular products, driving the preparation, review and authoring of submissions including post approval supplements, amendments, notifications and annual reports.
Brian Park
LinkedInExperience: Principal Regulatory Affairs Specialist · Boston Scientific
Former Principal Regulatory Affairs Specialist at Boston Scientific (2002–2010), a role the profile describes as responsible for FDA PMA Supplements, PMA 30-day Notices, PMA Annual Reports and 510(k), along with writing 9 Technical Files for Class IIb devices. The listing also shows Manager, Regulatory Affairs at Volcano Corporation (2011–2016) and Principal Regulatory Affairs Specialist at Philips Image Guided Therapy Devices (2017–2024).
Kathy Mah
LinkedInExperience: Senior Regulatory Project Manager · Saluda Medical
Senior Regulatory Project Manager at Saluda Medical since 2017. The profile describes compiling the original PMA for the Evoke Spinal Cord Stimulation System, along with amendments and supplements, and developing Q-Submission and Submission Issue Request packages, and coordinating in-person meetings and teleconferences. Other listed roles include Senior Regulatory Engineer at Spinal Modulation / St. Jude Medical (2011–2017) and Sr. Regulatory Engineer at Satiety, Inc. (2009–2010).
Kelly Nguyen
LinkedInExperience: Senior Manager, Regulatory Affairs · Advanced Bionics
Senior Manager, Regulatory Affairs at Advanced Bionics since December 2025; the listing also shows Principal Regulatory Affairs Specialist (2024–2025) and Senior Regulatory Affairs Specialist (2021–2024) roles there. The profile describes preparing and submitting 180 Day PMA Supplements, 30 Day Notices and annual reports, and managing sustaining projects with regulatory impact. Other listed roles include Regulatory Affairs Specialist II at Abbott (2018–2021).
Larry Picciano
LinkedInExperience: Director Worldwide Regulatory Affairs · Johnson & Johnson MedTech
Former Director Worldwide Regulatory Affairs at Johnson & Johnson MedTech (2014–2017). The profile describes designing and implementing new PMA Q&R policies and procedures across the J&J diabetes care franchise and leading a regulatory and quality program to upgrade systems from class II to III. Vice President, Regulatory Affairs at Impulse Dynamics since May 2025, and Sr. Vice President, Product Engineering, Regulatory Affairs, Quality Assurance at PoNS Therapy (2018–2025).
Linh Latchman, RAC
LinkedInExperience: Regulatory Affairs Manager · Neovasc Inc.
Regulatory Affairs Manager at Neovasc Inc. since February 2020, and Sr. Regulatory Affairs Specialist there from 2015 to 2017. The profile describes managing the preparation, review and submission of Class III device submissions, including a 180-day PMA supplement for a software app and a 30-day manufacturing change, and contributing to an on-time annual PMA report. Other listed roles include Principal Regulatory Affairs Specialist at Coloplast (2017–2018).
Plessy Paul, MS, RAC
LinkedInExperience: Regulatory Affairs Manager · Shockwave Medical
Former Regulatory Affairs Manager at Shockwave Medical (2021–2022) and Sr Manager Regulatory Affairs at Imperative Care since February 2025. The profile describes the creation, preparation and submission of PMA supplements for Class III active implantable devices and remote care medical devices, and setting regulatory strategies for US and international submissions on cross-functional teams. Also Senior Regulatory Affairs Specialist at St. Jude Medical (2010–2016).
Sanjay Sharma, PhD, RAC, MBA
LinkedInExperience: Head of Regulatory Affairs for Aneurysm and Peripheral Devices · MicroVention-Terumo
Head of Regulatory Affairs for Aneurysm and Peripheral Devices at MicroVention-Terumo since August 2022. The profile lists reviewing, approving and preparing regulatory submissions for Class III PMA and AIMDD devices and communicating with regulatory agencies including FDA. Other listed roles include Vice President Regulatory Affairs & Quality Assurance at Mainstay Medical (2021–2022) and RA Leader for Hemorrhagic Stoke Portfolio Devices Senior Manager Regulatory Affairs at Medtronic (2015–2021).
Choose the right perspective
Match the person's experience to your stage, since compiling an original PMA differs from running a steady flow of PMA supplements, 30-day notices and annual reports for a device already on the market. Also consider device type and company size, because an implantable device at a startup raises different FDA questions than a portfolio inside a large manufacturer.
Questions to take into the conversation
- 01How do you decide whether a device change needs a 180-day supplement, a real-time review supplement or a 30-day notice?
- 02What do you put in place early so an original PMA does not stall in FDA review?
- 03How do you keep PMA annual reports and post-approval obligations on track across a product portfolio?
Reaching FDA PMA submissions experts
How can I contact one of these FDA PMA submissions experts?
Pick one of the 10 people on this page and choose "Book a paid call", or describe your project to find others. You offer a fee for a 15-minute call or a written answer, Instant Expert finds the person's work email and sends the invitation, and they decide whether to accept. The list covers 10 companies, including Codman & Shurtleff Inc., a Johnson & Johnson Company; Cordis and Recor Medical, based on profile data retrieved on October 3, 2026. Being listed here doesn't mean someone has agreed to take calls.
How much does it cost to reach FDA PMA submissions experts?
You choose the offer, starting at $5 per person. It includes Instant Expert's 20% fee, so an offer that pays the person $100 costs you $125. You're charged only when the person books the call or sends the answer.
What if they don't reply?
You pay nothing. Instant Expert sends follow-up reminders, and if the person hasn't booked or answered within 7 days, the request expires and any hold on your card is released. You can invite several of the 10 people on this list at once and cap your total spend, so you pay only for the ones who accept.
About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot and may describe past or present roles. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.
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