- Device
- TactiSys™ Quartz Equipment
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S078
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2022-04-27
- Decision code
- APPR
- Date received
- 2022-01-27
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the TactiSys Quartz Equipment SW v1.7.2 software maintenance release to disable the charging of a non-rechargeable Real Time Clock (RTC) battery.