PMA P910001S085

Device: SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S085
Product code: LPC
Decision date: 2016-04-13
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
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: SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S085
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
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.