|
Device | iCast Covered Stent System |
Generic Name | Iliac covered stent, arterial |
Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. HUDSON, NH 03051 |
PMA Number | P120003 |
Supplement Number | S003 |
Date Received | 09/20/2023 |
Decision Date | 10/18/2023 |
Product Code |
PRL |
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 changes to the annealing of the Stainless Steel Tubing used to form the stent |