PMA P130026S034
- Device
- TactiCath Quartz Equipment
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S034
- Product code
- OAE
- Decision date
- 2018-10-15
- 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 TactiSys Quartz motherboard and software changes.
Current openFDA PMA Record#
- Device
- TactiCath Quartz Equipment
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S034
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2018-10-15
- Decision code
- APPR
- Date received
- 2018-07-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for TactiSys Quartz motherboard and software changes.