BLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS
FDA premarket approval P020025/S051 · decided 2013-12-18
Approval details
- PMA number
- P020025
- Supplement
- S051
- Supplement type
- 30-Day Notice
- Trade name
- BLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2013-11-21
- Decision date
- 2013-12-18
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- VENDOR MANUFACTURING CHANGES FOR THE BLAZER II, BLAZER II HTD, BLAZER PRIME HTD, BLAZER II XP, AND BLAZER PRIME XP ABLATION CATHETERS.
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