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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCORONARY BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon angioplasty
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP880055
Date Received07/18/1988
Decision Date09/26/1990
Withdrawal Date 09/27/2007
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 90M-0437
Notice Date 01/16/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S002 S003 
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