Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | BioMimics 3D Vascular Stent System |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | Veryan Medical Ltd. Unit 15, City Business Centre, Brighton Rd Horsham RH13 |
PMA Number | P180003 |
Supplement Number | S002 |
Date Received | 03/16/2020 |
Decision Date | 04/10/2020 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement In-process stent quality control changes, a component supplier manufacturing location change and part number changes. |
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