Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo SP Ablation Catheter
FDA premarket approval P110016/S046 · decided 2017-05-19
Approval details
- PMA number
- P110016
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo SP Ablation Catheter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-05-04
- Decision date
- 2017-05-19
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Replacement equipment for final inspection.
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510(k) clearances by this applicant
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