PMA P910001S109

Device: CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S109
Product code: LPC
Decision date: 2019-03-20
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: Approval for a supplier change for the luer leg subcomponent, process change related to the luer leg, and an additional quality control inspection for the luer leg.

Current openFDA PMA Record#

Device: CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S109
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2019-03-20
Decision code: APPR
Date received: 2018-12-26
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a supplier change for the luer leg subcomponent, process change related to the luer leg, and an additional quality control inspection for the luer leg.