FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE)
FDA premarket approval P110016/S057 · decided 2018-06-13
Approval details
- PMA number
- P110016
- Supplement
- S057
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE)
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-05-18
- Decision date
- 2018-06-13
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for updating Connector assembly and associated manufacturing for including a temporary grommet to improve reliability of the FlexAbility catheter.
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