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 | QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable |
Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Applicant | Biosense Webster, Inc. 31 Technology Drive, Suite 200 Irvine, CA 92618 |
PMA Number | P210027 |
Supplement Number | S002 |
Date Received | 03/21/2023 |
Decision Date | 07/20/2023 |
Product Codes |
OAD OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P210027. |
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