BLAZER PRIME XP,INTELLATIP MIFI XP, BLAZER II XP TEMPERATURE ABLATION CATHETERS
FDA premarket approval P020025/S082 · decided 2016-04-28
Approval details
- PMA number
- P020025
- Supplement
- S082
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER PRIME XP,INTELLATIP MIFI XP, BLAZER II XP TEMPERATURE ABLATION CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2015-11-20
- Decision date
- 2016-04-28
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a vendor change to manufacture the tube braid component, including a resin material change, used on the ablation catheters.
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