PMA P130026S006
- Device
- TACTICATH QUARTZ SET
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S006
- Product code
- OAE
- Decision date
- 2015-08-20
- 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 TO MODIFY HOW THE PROXIMAL END OF THE PULLWIRE IS ATTACHED TO THE CATHETER¿S HANDLE.
Current openFDA PMA Record#
- Device
- TACTICATH QUARTZ SET
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S006
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2015-08-20
- Decision code
- APPR
- Date received
- 2015-07-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO MODIFY HOW THE PROXIMAL END OF THE PULLWIRE IS ATTACHED TO THE CATHETER¿S HANDLE.