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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.
 
DeviceAORTIC VALVULOPLASTY BALLOON DILATATION CATHETER
Generic NamePULSE-GENERATOR, PROGRAM MODULE
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP880065
Supplement NumberS005
Date Received02/27/2001
Decision Date03/27/2001
Withdrawal Date09/20/2007
Product Code LOT 
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  
CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.
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