PMA P910001S023

Device: CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S023
Product code: LPC
Decision date: 2003-05-02
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: APPROVAL FOR THE REVISED INSTRUCTIONS FOR USE THAT INCLUDE THE ADJUDICATED RESULTS FROM THE LARS INVESTIGATION.

Current openFDA PMA Record#

Device: CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S023
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2003-05-02
Decision code: APPR
Date received: 2003-01-31
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE REVISED INSTRUCTIONS FOR USE THAT INCLUDE THE ADJUDICATED RESULTS FROM THE LARS INVESTIGATION.