PMA P020025S081
- Device
- BLAZER II XP, BLAZER PRIME XP AND INTELLA TIP MIFI XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S081
- Product code
- OAD
- Decision date
- 2015-12-17
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- ADDITIONAL SUPPLIER FOR THE STEERING CONTROL WIRE.
Current openFDA PMA Record#
- Device
- BLAZER II XP, BLAZER PRIME XP AND INTELLA TIP MIFI XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S081
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2015-12-17
- Decision code
- OK30
- Date received
- 2015-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL SUPPLIER FOR THE STEERING CONTROL WIRE.