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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.
 
DeviceBOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER
Generic NamePULSE-GENERATOR, PROGRAM MODULE
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP880065
Supplement NumberS006
Date Received07/12/2001
Decision Date07/30/2001
Withdrawal Date09/20/2007
Product Code LOT 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.
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