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 | CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | ABBOTT VASCULAR DEVICES 400 SAGINAW DR. REDWOOD CITY, CA 94063 |
PMA Number | P910031 |
Supplement Number | S007 |
Date Received | 01/26/1996 |
Decision Date | 05/30/1996 |
Reclassified Date
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10/08/2011 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1)AN ADDITIONAL MANUFACTURING SITE (13900 ALTON PARKWAY, SUITE 122, IRVINE, CA, 92718); 2) AN ALTERNATE STERILIZATION SITE (GRIFFITH MICRO SCIENCE, 4900 GIFFORD AVE., LOS ANGELES, CA, 90058); AND 3) AN INCREASE IN THE SHELF LIFE FROM ONE TO TWO YEARS |
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