PMA P040042S031
- Device
- THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S031
- Product code
- OAD
- Decision date
- 2016-04-29
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
Current openFDA PMA Record#
- Device
- THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S031
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2016-04-29
- Decision code
- APPR
- Date received
- 2015-08-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.