BLAZER II XP CARDIAC ABLATION CATHETER
FDA premarket approval P020025/S061 · decided 2014-12-08
Approval details
- PMA number
- P020025
- Supplement
- S061
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER II XP CARDIAC ABLATION CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2014-06-13
- Decision date
- 2014-12-08
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
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