PMA P150005S002
- Device
- BLAZER OPEN-IRRIGATED ABLATION CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S002
- Product code
- OAD
- Decision date
- 2016-03-30
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Change to add three ethylene oxide sterilization chambers to the BSC Coventry Rhode Island facility.
Current openFDA PMA Record#
- Device
- BLAZER OPEN-IRRIGATED ABLATION CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S002
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2016-03-30
- Decision code
- OK30
- Date received
- 2016-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to add three ethylene oxide sterilization chambers to the BSC Coventry Rhode Island facility.