|
Device | HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510 |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P980043 |
Supplement Number | S015 |
Date Received | 11/13/2007 |
Decision Date | 12/12/2007 |
Product Code |
DYE |
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 THE ADDITION OF A CAUTION STATEMENT TO THE LABELING. |