INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER
FDA premarket approval P020025/S072 · decided 2015-06-12
Approval details
- PMA number
- P020025
- Supplement
- S072
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2015-05-13
- Decision date
- 2015-06-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE DISTANCE OF MEASURE IN THE MINI ELECTRODE AND SEVERAL MINOR ADJUSTMENTS TO THE LASER MICROMETER.
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