PMA P960042S002

Device: 14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S002
Decision date: 1998-09-04
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.

Current openFDA PMA Record#

Device: 14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S002
Decision date: 1998-09-04
Decision code: APPR
Date received: 1998-03-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.