Therapy Cool Path Duo, Safire BLU Duo, Cool Path, Duo, Safire Duo, Therapy Cool Path Duo SP, Safire, BLU Duo SP and Ther
FDA premarket approval P110016/S073 · decided 2021-03-12
Approval details
- PMA number
- P110016
- Supplement
- S073
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Therapy Cool Path Duo, Safire BLU Duo, Cool Path, Duo, Safire Duo, Therapy Cool Path Duo SP, Safire, BLU Duo SP and Ther
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-01-13
- Decision date
- 2021-03-12
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for minor design changes to a printed circuit board assembly and a change in supplier for the manufacture of the printed circuit board assembly.
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510(k) clearances by this applicant
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|---|---|---|
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |