BLAZER II XP & BLAZER PRIME XP CATHETERS
FDA premarket approval P020025/S027 · decided 2011-07-27
Approval details
- PMA number
- P020025
- Supplement
- S027
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER II XP & BLAZER PRIME XP CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2011-03-23
- Decision date
- 2011-07-27
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION CYCLE.
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