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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.
 
Device14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE
ApplicantSpectranetics (Philips)
9965 Federal Drive
Colorado Springs, CO 80921
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/Material
Expedited Review Granted? No
Combination ProductNo
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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