Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C
FDA premarket approval P110016/S053 · decided 2018-03-06
Approval details
- PMA number
- P110016
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-02-05
- Decision date
- 2018-03-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Alternative Electrical Safety Test for the Ampere Generator, Ampere Remote Control and TactiSys Quartz Equipment.
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