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 | QWIKSTAR DIAGNOSTIC/ABLATION CATHETERS (MODELS D-1229 AND D-1230) AND QWIKSTAR INTERFACE CABLE (MODEL D-1195-12) |
Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Regulation Number | 870.1220 |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990025 |
Supplement Number | S004 |
Date Received | 04/01/2002 |
Decision Date | 12/18/2002 |
Product Code |
DRF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW INTERFACE CABLE AND DESIGN CHANGES (E.G., ADDITIONAL LOCATION SENSOR) TO THE CATHETER PREVIOUSLY APPROVED UNDER P990025 AND IT'S SUPPLEMENTS, IN ORDER TO ENABLE ADDITIONAL MAPPING CAPABILITIES. |
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