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 | AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER |
Generic Name | PULSE-GENERATOR, PROGRAM MODULE |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P880065 |
Supplement Number | S007 |
Date Received | 05/29/2002 |
Decision Date | 06/25/2002 |
Withdrawal Date
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09/20/2007 |
Product Code |
LOT |
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 ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS. |
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