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 | MEDTRONIC(R) CORONARY BALLOON DILATATION CATHETERS MODELS 18K, 14K SPIRT, EVERGREEN, FALCON AND PANTHER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 3576 UNO CAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P870036 |
Supplement Number | S035 |
Date Received | 04/07/1995 |
Decision Date | 04/27/1995 |
Withdrawal Date
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06/09/2008 |
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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