Atlas FDA

TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C

FDA premarket approval P220013 · decided 2023-05-18

Approval details

PMA number
P220013
Trade name
TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant
ABBOTT MEDICAL
Date received
2022-08-15
Decision date
2023-05-18
Days to decision
276 days
Decision code
APPR
Product code
OAE
Advisory committee
Cardiovascular
Expedited review
No
Location
Plymouth, MN
Statement
Approval for the TactiFle Ablation Catheter, Sensor Enabled. This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system.

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

510(k) clearances by this applicant

RecordFirmDate
EnSite™ X EP System (K262006)Abbott Medical2026-07-15
Amplatzer TorqVue Exchange System (K261631)Abbott Medical2026-06-17
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459)ABBOTT MEDICAL2026-04-24
EnSite™ X EP System (K260212)ABBOTT MEDICAL2026-04-20
Disposable Radiofrequency Cannula (K253907)ABBOTT MEDICAL2026-04-16
Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499)ABBOTT MEDICAL2026-03-13
Armada™ 14 NC PTA Catheter (K252512)ABBOTT MEDICAL2026-02-13
Assert-IQ (DM5100) (K253516)ABBOTT MEDICAL2025-12-18