FlexAbility and FlexAbility SE Ablation Catheter; FlexAbility Cables, Sensor Enabled
FDA premarket approval P110016/S059 · decided 2019-03-05
Approval details
- PMA number
- P110016
- Supplement
- S059
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FlexAbility and FlexAbility SE Ablation Catheter; FlexAbility Cables, Sensor Enabled
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-02-14
- Decision date
- 2019-03-05
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for an alternate sterilization site located at Sterigenics, 5725 Harold Gatty Drive, Salt Lake City, Utah.
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510(k) clearances by this applicant
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| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |