BLAZER II XP CATHETERS
FDA premarket approval P020025/S021 · decided 2011-01-26
Approval details
- PMA number
- P020025
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER II XP CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2009-06-03
- Decision date
- 2011-01-26
- Days to decision
- 602 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN HEREDIA, COSTA RICA.
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