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 | PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | BOSTON SCIENTIFIC One Scimed Place Maple Grove, MN 55311 |
PMA Number | P880027 |
Supplement Number | S062 |
Date Received | 05/29/2002 |
Decision Date | 06/25/2002 |
Withdrawal Date
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04/13/2007 |
Product Code |
LOX |
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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