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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.
 
DeviceManual Retraction Kit
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMedtronic Cryocath, LP
8200 Coral Sea St., Ms Mv S46
Mounds View, MN 55112
PMA NumberP100010
Supplement NumberS149
Date Received09/12/2024
Decision Date11/13/2024
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the addition of the Centerpiece (Tijuana, Mexico) as an alternate Ethylene Oxide (EO) sterilization vendor for the Manual Retraction Kit (20MRK) and Coaxial Umbilical Cable (203CX and 203CXC)
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