BLAZER II XP,BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
FDA premarket approval P020025/S055 · decided 2014-04-04
Approval details
- PMA number
- P020025
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Trade name
- BLAZER II XP,BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2014-03-04
- Decision date
- 2014-04-04
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ACCEPTANCE FOR BIOBURDEN TESTING TO BE COMPLETED AT AN ALTERNATE FACILITY
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