|
Device | VASCADE VASCULAR CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | CARDIVA MEDICAL, INC. 2900 LAKESIDE DRIVE SUITE 160 Santa Clara, CA 95054 |
PMA Number | P120016 |
Supplement Number | S016 |
Date Received | 06/29/2015 |
Decision Date | 07/29/2015 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE FOR THE IMPLEMENTATION OF AN ALTERNATIVE TECHNIQUE FOR RELEASE OF COLLAGEN FROM THE VASCADE DEVICE. |