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 | MEDTRONIC MOSAIC PORCINE BIOPROSTHESES MODEL 305 (AORTIC) AND MODEL 310 (MITRAL) |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P990064 |
Supplement Number | S004 |
Date Received | 08/29/2000 |
Decision Date | 06/07/2001 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE MEDTRONIC MOSAIC PORCINE BIOPROSTHESES, MODEL 305 (AORTIC) AND MODEL 310 (MITRAL). |
|
|