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. |
|
Device | QDOT MICRO™ System |
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 | S006 |
Date Received | 02/27/2024 |
Decision Date | 03/25/2024 |
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 an alternate sub-tier supplier for the catheter printed circuit board subassembly |
|
|