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 | USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | USCI, DIV. C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 BILLERICA, MA 01821 |
PMA Number | P890048 |
Supplement Number | S004 |
Date Received | 04/10/1995 |
Decision Date | 06/14/1995 |
Reclassified Date
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10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Supplement |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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