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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 NameFACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter with ultrasound
Regulation Number870.5100
ApplicantCARDIOVASCULAR DYNAMICS, INC.
PMA NumberP910031
Supplement NumberS011
Date Received08/26/1996
Decision Date04/09/1997
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 following: 1) a change in the balloon design from a double layer of polyethylene with a polyethylene terephalate center region to a single layer of polyethylene terephalate; 2) a change in catheter shaft material from polyethylene to nylon; 3) a change in the internal shaft design from a two lumen side by side design to a two lumen coaxial design; 4) a change in the balloon/shaft bonding method from heat sealing to a urethane adhesive; 5) a change in the balloon lengths from 25 mm to 22 mm and from 20 mm to 18 mm; and 6) a change in the color of the catheter shaft from blue to teal.
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