TactiFlex Ablation CatTactiFlex Ablation Catheter, Sensor Enabledheter, Sensor Enabled, TactiSys Quartz Equipment,
FDA premarket approval P220013/S008 · decided 2023-10-26
Approval details
- PMA number
- P220013
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TactiFlex Ablation CatTactiFlex Ablation Catheter, Sensor Enabledheter, Sensor Enabled, TactiSys Quartz Equipment,
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-09-08
- Decision date
- 2023-10-26
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for the addition of Centerpiece as an alternative sterilization site for products manufactured at Abbotts Plymouth, MN; Minnetonka, MN; and Costa Rica sites.
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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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| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) | ABBOTT MEDICAL | 2026-04-24 |
| EnSite™ X EP System (K260212) | ABBOTT MEDICAL | 2026-04-20 |
| 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 |