PMA P920047S103
- Device
- Blazer II HTD / Blazer Prime HTD
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S103
- Product code
- LPB
- Decision date
- 2017-10-11
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Implementation of an automated wire pulling and stripping process.
Current openFDA PMA Record#
- Device
- Blazer II HTD / Blazer Prime HTD
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S103
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2017-10-11
- Decision code
- OK30
- Date received
- 2017-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an automated wire pulling and stripping process.