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 | NAVISTAR |
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 | S067 |
Date Received | 06/30/2021 |
Decision Date | 03/08/2022 |
Product Code |
DRF |
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 nGEN Generator (compatible with the THERMOCOOL, NAVISTAR and CELSIUS catheters), the addition of a manufacturing site in Israel to manufacture the nGEN Generator and nGEN Pump, and the addition of a manufacturing site in Mexico to manufacture the Interface Cable between the CELSIUS catheters to the nGEN Generator. |
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