PMA P210027S018
- Device
- QDOT MICRO™ System
- Applicant
- Biosense Webster, Inc.
- PMA number
- P210027
- Supplement
- S018
- Product code
- OAE
- Decision date
- 2026-09-10
- Classification
- Cardiovascular
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- to implement a repackaging and relabeling operation
Current openFDA PMA Record#
- Device
- QDOT MICRO™ System
- Applicant
- Biosense Webster, Inc.
- PMA number
- P210027
- Supplement
- S018
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2026-09-10
- Decision code
- OK30
- Date received
- 2026-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a repackaging and relabeling operation