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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
Classification Namepulse-generator, program module
Generic Namepulse-generator, program module
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311
PMA NumberP880065
Supplement NumberS005
Date Received02/27/2001
Decision Date03/27/2001
Product Code
LOT
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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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