PMA P960042S042

Device: SPECTRANETICS LASER SHEATH (SLS) II AND GLIDELIGHT LASER SHEATH
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S042
Product code: MFA
Decision date: 2012-10-31
Classification: Device, Removal, Pacemaker Electrode, Percutaneous
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Approval order statement: APPROVAL FOR MODIFYING THE SLS II AND GLIDELIGHT INSTRUCTION FOR USE MANUALS TO INCLUDE A WARNING AND PRECAUTION STATEMENT AND STRENGTHEN A WARNING.

Current openFDA PMA Record#

Device: SPECTRANETICS LASER SHEATH (SLS) II AND GLIDELIGHT LASER SHEATH
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S042
Product code: MFA
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Decision date: 2012-10-31
Decision code: APPR
Date received: 2012-10-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFYING THE SLS II AND GLIDELIGHT INSTRUCTION FOR USE MANUALS TO INCLUDE A WARNING AND PRECAUTION STATEMENT AND STRENGTHEN A WARNING.