Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | KNOT PUSHER WITH TRIMMER(TM) |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S027 |
Date Received | 09/13/2000 |
Decision Date | 10/17/2000 |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL IS FOR THE KNOT PUSHER WITH TRIMMER, AN ACCESSORY TO THE CLOSER 6 FR. SMC SYSTEM AND THE CLOSER S 6 FR. SMC SYSTEM |
|
|