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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 NameACS SPECTRUM(TM) CORONARY DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon dilatation catheter
Regulation Number870.5100
ApplicantADVANCED CATHETER SYSTEMS
PMA NumberP810046
Supplement NumberS103
Date Received05/23/1991
Decision Date06/25/1991
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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