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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 RX COMET CORONARY DILATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
PMA NumberP810046
Supplement NumberS171
Date Received12/23/1996
Decision Date05/12/1997
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
Approval Order Statement 
Approval for the acs rx comet(tm) coronary dilatation catheter with the 40 mm balloon lengths with the half sizes (i. E. , 2. 0 mm, 2. 5 mm, 3. 0 mm, 3. 5 mm, 4. 0 mm), the 15 mm balloon lengths with the quarter sizes (i. E. , 2. 75 mm, 3. 25 mm and 3. 75 mm diameters), the 30 mm balloon lengths (i. E. , 2. 75 mm, 3. 25 mm, 3. 75 mm and 4. 0 mm diameters) and a single 20 mm balloon length (i. E. , 1. 5 mm) and modification of the balloon compliance chart of the acs rx comet(tm) coronary dilatation catheter to inlcude data up to 18 atm for balloons with a rated burst pressure (rbp) of 14 atm to be consistent with other ptca manufacturers.
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