FlexAbility Ablation Catheters (Bi & Uni Directional)
FDA premarket approval P110016/S034 · decided 2017-09-29
Approval details
- PMA number
- P110016
- Supplement
- S034
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FlexAbility Ablation Catheters (Bi & Uni Directional)
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-06-24
- Decision date
- 2017-09-29
- Days to decision
- 462 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for changes to the tip-to-shaft adhesive bond assembly process utilized in the distal shaft of the FlexAbility Ablation Catheters (Bi-Directional and Uni-Directional).
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