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 | VISITAG SURPOINT External Processing Unit (EPU) |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S110 |
Date Received | 11/20/2020 |
Decision Date | 11/12/2021 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT03624881
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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 changes to the Indications for Use and the Instructions for Use (IFU) for the VISITAG SURPOINT External Processing Unit (EPU). |
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