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 | MASTERS SERIES VALVE: PTFE SEWING CUFF |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S052 |
Date Received | 05/22/2000 |
Decision Date | 06/30/2000 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO REMOVE THE CONDITION OF APPROVAL IN THE JULY 23,1998 APPROVAL ORDER THAT THE FIRM PROVIDE RESULTS FROM TESTS WHICH DEMONSTRATE THE LONG-TERM INTEGRITY OF THE SEWING CUFF ATTACHMENT MECHANISM OF THE ST. JUDE MEDICAL(R) MASTER SERIES VALVE MODELS. |
|
|