| Device | QDOT MICRO™ System |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | Biosense Webster, Inc.31 Technology Drive, Suite 200irvine, CA 92618 PMA NumberP210027 Date Received07/06/2021 Decision Date11/23/2022 Product Codes OAD OAE Advisory Committee Cardiovascular Clinical TrialsNCT03775512 Expedited Review Granted? No |
| Date Received | 2021-07-06 |
| Decision Date | 2022-11-23 |
| PMA | P210027 |
| Supplement | S |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Biosense Webster, Inc. 31 Technology Drive, Suite 200 irvine, CA 92618 PMA NumberP210027 Date Received07/06/2021 Decision Date11/23/2022 Product Codes OAD OAE Advisory Committee Cardiovascular Clinical TrialsNCT03775512 Expedited Review Granted? No Combination ProductNo Approval Order Statement The Biosense Webster QDOT MICRO™ Catheter And Related Accessory Devices Are Indicated For Catheter-based Cardiac Electrophysiological Mapping (stimulating And Recording) And, When Used With A Compatible RF Generator, For The Treatment Of:• Type I Atrial Flutter In Patients Age 18 Or Older• Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation, When Used With Compatible Three-dimensional Electroanatomic Mapping Systems. The QDOT MICRO™ Catheter Provides A Real-time Measurement Of Contact Force Between The Catheter Tip And Heart Wall, As Well As Location Information When Used With CARTO® 3 Navigation System. Supplements: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210027 | Original Filing |
| Device ID | PMA | Supp |
|---|---|---|
| 10846835016796 | P210027 | 000 |
| 10846835017434 | P210027 | 001 |
| 10846835017427 | P210027 | 001 |