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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 MC RAIL(TM) 20,30,40 SLIDING RAIL PTCA
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namesliding rail ptca
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP880027
Supplement NumberS028
Date Received10/20/1993
Decision Date04/29/1994
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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