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/S058 · decided 2019-01-10
Approval details
- PMA number
- P110016
- Supplement
- S058
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2018-12-12
- Decision date
- 2019-01-10
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for updates to the warnings section of the Instructions for Use for Ampere Generator and its accessories.
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510(k) clearances by this applicant
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