Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo Ablation Catheter, Safire Duo Ablation Catheter, MediGuide En
FDA premarket approval P110016/S071 · decided 2020-10-16
Approval details
- PMA number
- P110016
- Supplement
- S071
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo Ablation Catheter, Safire Duo Ablation Catheter, MediGuide En
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-09-18
- Decision date
- 2020-10-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Alternative batch sampling for bacterial endotoxin testing.
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510(k) clearances by this applicant
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|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
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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 |