- Device
- QDOT MICRO™ System
- Applicant
- Biosense Webster, Inc.
- PMA number
- P210027
- Supplement
- S016
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2026-04-17
- Decision code
- APPR
- Date received
- 2026-03-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for modifications to the device labeling, including addition of information related to potential adverse reactions