FLEXABILITY ABLATION CATHETER, THERAPY COOL PATH DUO, SAFIRE BLU DUO, COOL PATH DUO, SAFIRE DUO, THERAPY COOL PATH DUO
FDA premarket approval P110016/S023 · decided 2015-10-21
Approval details
- PMA number
- P110016
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLEXABILITY ABLATION CATHETER, THERAPY COOL PATH DUO, SAFIRE BLU DUO, COOL PATH DUO, SAFIRE DUO, THERAPY COOL PATH DUO
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-09-23
- Decision date
- 2015-10-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
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