PMA P130026S074
- Device
- TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE)
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S074
- Product code
- OAE
- Decision date
- 2021-06-25
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Alternate supplier for a spooled wire and electrode subassembly.
Current openFDA PMA Record#
- Device
- TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE)
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S074
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-06-25
- Decision code
- OK30
- Date received
- 2021-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for a spooled wire and electrode subassembly.