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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 NameEXTREME XTO .9 MM CORONARY ANGIOPLASTY CATHETER
Classification Namedevice, angioplasty, laser, coronary
Generic Namedevice, angioplasty, laser, coronary
ApplicantSPECTRANETICS CORP.
PMA NumberP910001
Supplement NumberS015
Date Received03/08/1999
Decision Date07/11/2000
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 
Approval for the extreme 0. 9 mm coronary angioplasty catheter.
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