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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 Name14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE
ApplicantSPECTRANETICS CORP.
PMA NumberP960042
Supplement NumberS002
Date Received03/09/1998
Decision Date09/04/1998
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 14 french (fr. ) and 16 fr. Laser sheath kits and individually packaged accessory devices (14 fr. And 16 fr. Outer sheaths and fish tape). The laser sheath kits include: one laser sheath (14 fr. Or 16 fr. ), two outer sheaths (14 fr. Or 16 fr. ), and a fish tape. The laser sheath kits, as modified, will be marketed under the trade names 14 fr. And 16 fr. Laser sheath kits and 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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