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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 NumberS002
Date Received03/31/1995
Decision Date10/23/1995
Withdrawal Date09/20/2007
Product Code LOT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW CONTRACT STERILIZER AND A CHANGE IN THE STERILIZATION PROCEDURE
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