PMA P020025S063
- Device
- INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S063
- Product code
- OAD
- Decision date
- 2014-07-18
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- MANUFACTURING CHANGE OF THE FINAL ELECTRICAL INSPECTION TEST METHOD.
Current openFDA PMA Record#
- Device
- INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S063
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2014-07-18
- Decision code
- OK30
- Date received
- 2014-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING CHANGE OF THE FINAL ELECTRICAL INSPECTION TEST METHOD.