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, Interface Cables |
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 | S003 |
Date Received | 05/17/2023 |
Decision Date | 06/12/2023 |
Product Codes |
OAD OAE |
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 Implementation of a new ethylene oxide sterilization cycle at the Sterigenics, Santa Teresa, NM facility. |
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