|
Device | Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100040 |
Supplement Number | S044 |
Date Received | 02/25/2021 |
Decision Date | 03/02/2021 |
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 Use of an electronic Manufacturing Execution System (MES) to replace the current paper-based device history record (DHR). |