PMA P960042S006

Device: LASER SHEATH
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S006
Decision date: 2001-01-17
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.

Current openFDA PMA Record#

Device: LASER SHEATH
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S006
Decision date: 2001-01-17
Decision code: APPR
Date received: 2000-08-11
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.