PMA P130026S032
- Device
- TatiCath Quartz Set
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S032
- Product code
- OAE
- Decision date
- 2018-05-16
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval for elimination of a field service procedure for the TactiSys Quartz equipment, and minor IFU revisions to reflect the removal of the service procedure.
Current openFDA PMA Record#
- Device
- TatiCath Quartz Set
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S032
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2018-05-16
- Decision code
- APPR
- Date received
- 2018-02-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for elimination of a field service procedure for the TactiSys Quartz equipment, and minor IFU revisions to reflect the removal of the service procedure.