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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 NameLASER SHEATH
ApplicantSPECTRANETICS CORP.
PMA NumberP960042
Supplement NumberS006
Date Received08/11/2000
Decision Date01/17/2001
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an increase in the laser "on" time to 10 seconds and a decrease in the laser "off" time to 5 seconds. These devices are indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
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