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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002
Classification Namedevice, angioplasty, laser, coronary
Generic Namedevice, angioplasty, laser, coronary
Applicant
SPECTRANETICS CORP.
9965 federal drive
colorado springs, CO 80921
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/material
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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