CHILLI II COOLED ABLATION SYSTEM
FDA premarket approval P020025/S076 · decided 2016-02-08
Approval details
- PMA number
- P020025
- Supplement
- S076
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CHILLI II COOLED ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2015-06-29
- Decision date
- 2016-02-08
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for a manufacturing site located in Heredia, Costa Rica.
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