Atlas FDA

FREEZOR CARDIAC/FREEZOR XTRA/FREEZOR MAX SURGICAL CARDIAC CRYOABLATION CATHETER/CCT.2 CRYOCONSOLE SYSTEM

FDA premarket approval P020045/S026 · decided 2009-07-07

Approval details

PMA number
P020045
Supplement
S026
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
FREEZOR CARDIAC/FREEZOR XTRA/FREEZOR MAX SURGICAL CARDIAC CRYOABLATION CATHETER/CCT.2 CRYOCONSOLE SYSTEM
Generic name
Cardiac ablation percutaneous catheter
Applicant
Medtronic Cryocath, LP
Date received
2009-03-09
Decision date
2009-07-07
Days to decision
120 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
Mounds View, MN
Statement
APPROVAL FOR A NEW CRYOABLATION CONSOLE WHICH INCLUDES CHANGES TO THE HARDWARE, SOFTWARE, USER INTERFACE, AND MECHANICAL CIRCUIT FOR THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CRYOCONSOLE, 7F FREEZOR XTRA SURGICAL CATHETER AND CRYOCONSOLE, AND 9F FREEZOR MAX SURGICAL CATHETER AND CRYOCONSOLE. THE NEW CRYOABLATION CONSOLE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYOCONSOLE TO BE USED WITH THE AFOREMENTIONED CATHETERS.

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