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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSCHNEIDER FREEHAND(TM) MODELS FH20-20,25,30,35,40
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP880027
Supplement NumberS029
Date Received11/05/1993
Decision Date12/07/1993
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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