BLAZER II XP CATHETERS
FDA premarket approval P020025/S019 · decided 2008-06-13
Approval details
- PMA number
- P020025
- Supplement
- S019
- 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
- 2007-03-12
- Decision date
- 2008-06-13
- Days to decision
- 459 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 BOSTON SCIENTIFIC CORPORATION, SAN JOSE, CALIFORNIA.
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