PMA P210027S012
- Device
- QDOT MICRO™ System
- Applicant
- Biosense Webster, Inc.
- PMA number
- P210027
- Supplement
- S012
- Product code
- OAE
- Decision date
- 2025-04-08
- Classification
- Cardiovascular
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- PAS protocol changes to retrospectively consent patients enrolled in REAL-AF Sites and to include the Zero/Low Fluoro Workflow.
Current openFDA PMA Record#
- Device
- QDOT MICRO™ System
- Applicant
- Biosense Webster, Inc.
- PMA number
- P210027
- Supplement
- S012
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2025-04-08
- Decision code
- APPR
- Date received
- 2024-07-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- PAS protocol changes to retrospectively consent patients enrolled in REAL-AF Sites and to include the Zero/Low Fluoro Workflow.