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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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter with ultrasound
Regulation Number870.5100
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.