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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFREEZOR/FREEZOR XTRA SURGICAL/FREEZOR MAX SURGICAL CATHETERS AND CRYOCONSOLE
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic Cryocath, LP
8200 Coral Sea St.
Mounds View, MN 55112
PMA NumberP020045
Supplement NumberS034
Date Received08/20/2010
Decision Date09/17/2010
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATE COMPONENTS FOR THE MANUFACTURING OF PRINTED CIRCUIT BOARD ASSEMBLIES.
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