BLAZER PRIME XP, BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
FDA premarket approval P020025/S070 · decided 2015-05-11
Approval details
- PMA number
- P020025
- Supplement
- S070
- Supplement type
- 30-Day Notice
- Trade name
- BLAZER PRIME 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
- 2015-04-28
- Decision date
- 2015-05-11
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ACCEPTANCE OF NEW MONITORING EQUIPMENT IN THE MICROBIOLOGY LAB AT THE HEREDIA, COSTA RICA LOCATION.
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