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Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters

FDA premarket approval P100010/S098 · decided 2020-06-23

Approval details

PMA number
P100010
Supplement
S098
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant
Medtronic Cryocath, LP
Date received
2019-10-25
Decision date
2020-06-23
Days to decision
242 days
Decision code
APPR
Product code
OAE
Advisory committee
Cardiovascular
Expedited review
No
Location
Mounds View, MN
Statement
Approval for the Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months). The Freezor MAX Cardiac Cryoablation Catheter is used as an adjunctive device in the endocardial treatment of paroxysmal and persistent atrial fibrillation (episode duration less than 6 months) in conjunction with the Arctic Front Cryocatheter fo

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510(k) clearances by this applicant

RecordFirmDate
FlexCath Advance Steerable Sheath and Dilator (K202620)Medtronic Cryocath, LP2020-11-13
FlexCath Advance Steerable Sheath and Dilator (K183174)Medtronic Cryocath, LP2018-11-26
FlexCath Select Steerable Shealth and Dilator (K163268)Medtronic Cryocath, LP2017-02-02
FlexCath Select Steerable Sheath (10 French) (K142684)Medtronic Cryocath, LP2014-11-06
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) (K123591)Medtronic Cryocath, LP2012-12-27
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 (K102176)Medtronic Cryocath, LP2010-09-01