BLAZER II XP, BLAZER XP RPM CARDIAC ABLATION CATHETERS
FDA premarket approval P020025/S013 · decided 2005-10-06
Approval details
- PMA number
- P020025
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER II XP, BLAZER XP RPM CARDIAC ABLATION CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2005-09-06
- Decision date
- 2005-10-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- MODIFICATIONS TO MANUFACTURING PROCEDURES AND MANUFACTURING INSTRUCTIONS.
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