|
Device | Tack Endovascular System (6F) |
Generic Name | Scaffold, dissection repair |
Applicant | Philips Image Guided Therapy Corporation 5905 Nathan Lane North Plymouth, MN 55442 |
PMA Number | P180034 |
Supplement Number | S002 |
Date Received | 03/17/2020 |
Decision Date | 04/15/2020 |
Product Code |
QCT |
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 Transfer of tube cutting processes to a new site. |