LASER SHEATH

FDA premarket approval P960042/S006 · decided 2001-01-17

Approval details

PMA number

P960042

Supplement

S006

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

LASER SHEATH

Applicant

Spectranetics (Philips)

Date received

2000-08-11

Decision date

2001-01-17

Days to decision

159 days

Decision code

APPR

Advisory committee

Cardiovascular

Expedited review

No

Location

Colorado Springs, CO

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.