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Spectranetics Laser Sheath SLSII

by Spectranetics (Philips)

PMA P960042

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

2 closed

Documents

PMA P960042↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP960042 Date9 Dec 1997ApprovedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1395-2012 FDA Not yet classified initiated 13 Mar 2012 on shared PMA P960042

    Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.

    • Terminated Z-1264-2009 FDA Unclassified (pre-2012) initiated 16 Mar 2009 on shared PMA P960042

    Catheter outer jacket may split during use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Spectranetics Cvx-300 Excimer Laser System & Laser Sheath
Generic Name
DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
PMA Number
FDA Product Code
MFA
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Spectranetics Laser Sheath SLSII is a percutaneous pacemaker electrode removal device designed for use in cardiovascular procedures. It serves as an adjunct to conventional lead extraction tools, specifically for patients requiring the removal of chronically implanted pacing or defibrillator leads with silicone or polyurethane insulation.

This device is supplied as a 12 French Laser Sheath Kit, which includes the Model 500-001 laser sheath and a fish tape accessory. The system has received FDA PMA authorization for its intended clinical application. It is designed for use by medical professionals in a clinical setting during transvenous lead extraction.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary use of the Spectranetics Laser Sheath SLSII?

    The device is used as an adjunct to conventional tools for the percutaneous transvenous removal of chronically implanted pacing or defibrillator leads that feature silicone or polyurethane outer insulation.

  • What components are included in the 12 French Laser Sheath Kit?

    The kit consists of the 12 French Laser Sheath, identified as Model 500-001, and a fish tape accessory used to assist in the lead extraction procedure.

  • Is this device FDA authorized?

    Yes, the Spectranetics Laser Sheath SLSII has received FDA PMA authorization for its use in the removal of pacemaker electrodes.