PMA P020025S061
- Device
- BLAZER II XP CARDIAC ABLATION CATHETER
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S061
- Product code
- OAD
- Decision date
- 2014-12-08
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
Current openFDA PMA Record#
- Device
- BLAZER II XP CARDIAC ABLATION CATHETER
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S061
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2014-12-08
- Decision code
- APPR
- Date received
- 2014-06-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.