PMA P150005S003
- Device
- BLAZER OPEN-IRRIGATED ABLATION CATHETER
- Applicant
- Boston Scientific Corp
- Product code
- OAD
- Decision date
- 2016-04-05
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Transfer of a production site for extruded components.
Current openFDA PMA Record#
- Device
- BLAZER OPEN-IRRIGATED ABLATION CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S003
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2016-04-05
- Decision code
- OK30
- Date received
- 2016-03-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of a production site for extruded components.