BLAZER II/BLAZER II XP CARDIAC ABLATION CATHETERS
FDA premarket approval P020025/S011 · decided 2005-06-17
Approval details
- PMA number
- P020025
- Supplement
- S011
- Supplement type
- Real-Time Process
- Trade name
- BLAZER II/BLAZER II XP CARDIAC ABLATION CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2005-05-19
- Decision date
- 2005-06-17
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE BLAZER II AND BLAZER II XP CATHETERS WITH MODIFIED MECHANICAL PERFORMANCE SPECIFICATIONS.
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