|
Device | Valiant Thoracic Stent Graft System (FreeFlo Tapers Line Extention) with Captivia Delivery System, Valiant Thoracic Sten |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100040 |
Supplement Number | S063 |
Date Received | 04/26/2024 |
Decision Date | 05/08/2024 |
Product Code |
MIH |
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 a reduction of cleanroom environmental monitoring testing locations |