PMA P130026S002
- Device
- TACTICATH QUARTZ SET
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S002
- Product code
- OAE
- Decision date
- 2015-03-26
- 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 CHANGES TO THE MANUFACTURING PROCESS AND AN ADDITIONAL INSPECTION ASSOCIATED WITH IRRIGATION TUBING
Current openFDA PMA Record#
- Device
- TACTICATH QUARTZ SET
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S002
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2015-03-26
- Decision code
- APPR
- Date received
- 2015-02-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE MANUFACTURING PROCESS AND AN ADDITIONAL INSPECTION ASSOCIATED WITH IRRIGATION TUBING