PMA P130026S014
- Device
- TACTICATH QUARTZ SET
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S014
- Product code
- OAE
- Decision date
- 2016-02-01
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Acceptance of an alternate supplier for proximal optical fiber components and acceptance of a proposed rework process for distal optical fiber components.
Current openFDA PMA Record#
- Device
- TACTICATH QUARTZ SET
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S014
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2016-02-01
- Decision code
- OK30
- Date received
- 2016-01-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Acceptance of an alternate supplier for proximal optical fiber components and acceptance of a proposed rework process for distal optical fiber components.