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. |
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Device | MOSAIC PORCINE BIOPROSTHESIS |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P990064 |
Supplement Number | S001 |
Date Received | 07/31/2000 |
Decision Date | 08/29/2000 |
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 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. IN ADDITION, THE QUALITY CONTROL TEST PERFORMED ON INCOMING INSPECTION WILL CHANGE FROM THE GRAVIMETRIC TEST METHOD TO THE NINHYDRIN TEST METHOD. |
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