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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 NameSIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon dilatation catheter
Regulation Number870.5100
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
PMA NumberP810046
Supplement NumberS160
Date Received11/22/1995
Decision Date12/28/1995
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications of the inflation/deflation notch of the above catheters and changes to the guide wire exit notch and proximal adatpion visual inspectin criteria of the rx lifestream catheter.
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