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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 NameVITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002
Classification Namedevice, angioplasty, laser, coronary
Generic Namecoronary angioplasty catheter
ApplicantSPECTRANETICS CORP.
PMA NumberP910001
Supplement NumberS019
Date Received12/21/2000
Decision Date06/19/2001
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Vitesse point 9mm x80 percutaneous coronary angioplasty catheter, model 110-004, and the extreme point 9mm x80 percutaneous coronary angioplasty catheter, model 110-002: 1) a change in the lasting time from 5 seconds on and 10 seconds off to 10 seconds on and 5 seconds off; 2) a change in the fluence and repetition rate from 30-60 fluence and 25-40 hz to 30-80 fluence and 25-80 hz; 3) a labeling change from "laser advancement of approximately 1 mm per second" to "maintain constant catheter tip contact with the lesion by applying mild forward pressure to the shaft of the catheter"; and 4) a change in the pin code on the coupler so that the catheters instruct the laser system to allow increased lasing parameters.
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