|
Device | CLOSER 6 FR. SUTURE-MEDIATED CLOSURE DEVICE |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S022 |
Date Received | 03/23/2000 |
Decision Date | 05/19/2000 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE MECHANISM FOR FOOT DEPLOYMENT AND FOOT PARKING OF THE CLOSER(TM) SMC DEVICE. |