|
Device | HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/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 | S001 |
Date Received | 04/08/2002 |
Decision Date | 04/16/2002 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO REVISE ONE CAUTION STATEMENT AND TO INCLUDE REFERENCES TO A NEW VALVE HANDLE (MODEL 7639) WITHIN THE INSTRUCTIONS FOR USE. |