|
Device | MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P970031 |
Supplement Number | S007 |
Date Received | 10/02/1998 |
Decision Date | 10/30/1998 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-day Notice requested a change in the method in which a raw material (AOA compound) is synthesized. This will result in the raw material being received in a more purified form. The quality control test performed in incoming inspection will change from the Gravimetric test method to the Ninhydrin test method. |