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 | ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S090 |
Date Received | 09/02/2022 |
Decision Date | 09/30/2022 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Add an additional chamber for the sterilization of catheters and cables at the Isomedix Operation, Inc. (Steris Grand Prairie) facility in Grand Prairie, Texas. |
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