|
Device | FREESTYLE AORTICROOT BIOPROSTHESIS |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P970031 |
Supplement Number | S032 |
Date Received | 02/15/2011 |
Decision Date | 04/15/2011 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO YOUR SECONDARY AND TERTIARY PACKAGING, INCLUDING THE ADDITION OF TWO NEW MATERIALS: A TEMPERATURE INDICATOR (TO BE PLACED IN THE SECONDARY PACKAGE) AND A CLEAR END SEAL LABEL. |