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 | SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | ABBOTT VASCULAR 26531 YNEZ ROAD BUILDING G MAILING P.O. 9018 TEMECULA, CA 92590 |
PMA Number | P890043 |
Supplement Number | S033 |
Date Received | 12/23/1998 |
Decision Date | 09/30/1999 |
Withdrawal Date
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09/05/2014 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the labeling for the Simpson Coronary AtheroCath(R) SCA-EX(TM), GTO(R), and BANTAM(TM) Atherectomy Catheters to 1) include clinical data from the Balloon versus Optimal Atherectomy Trial (BOAT) and 2) streamline the remainder of the text. |
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