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 |
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 | S003 |
Date Received | 06/02/1995 |
Decision Date | 12/07/1995 |
Reclassified Date
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10/08/2011 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ENDOSONICS ORACLE FOCUS PTCA CATHETER, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ENDOSONICS ORACLE FOCUS PTCA CATHETER |
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