PMA P960042S053

Device: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S053
Product code: MFA
Decision date: 2016-04-13
Classification: Device, Removal, Pacemaker Electrode, Percutaneous
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Approval order statement: Approval for the addition of warnings to the Directions for Use (DFU) of the associated Laser Catheters included in the Laser System.

Current openFDA PMA Record#

Device: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
Applicant: Spectranetics (Philips)
PMA number: P960042
Supplement: S053
Product code: MFA
Generic name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Decision date: 2016-04-13
Decision code: APPR
Date received: 2016-03-14
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of warnings to the Directions for Use (DFU) of the associated Laser Catheters included in the Laser System.