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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.
 
DeviceMANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
Generic NamePULSE-GENERATOR, PROGRAM MODULE
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP880065
Supplement NumberS003
Date Received03/05/1997
Decision Date09/08/1997
Withdrawal Date09/20/2007
Product Code LOT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for: 1) an alternate manufacturing and sterilization facility; 2) use of the Oxyfume 2000 sterilant gas mixture for sterilization; 3) use of a parametric release instead of the biological indicators product release process; and 4) use of a revised labeling format, which replaces the Mansfield name with the SCIMED(R) name.
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