PMA P910001S020

Device: CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S020
Product code: LPC
Decision date: 2001-10-10
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: APPROVAL FOR AN ADDITIONAL INDICATION, THE TREATMENT OF RESTENOSIS IN 316L STAINLESS STEEL STENTS, PRIOR TO THE ADMINISTRATION OF INTRAVASCULAR BRACHYTHERAPY, FOR THE CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM. THE INDICATION IS IN ADDITION TO THOSE LISTED IN THE FEBRUARY 19, 1993, APPROVAL LETTER.

Current openFDA PMA Record#

Device: CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S020
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2001-10-10
Decision code: APPR
Date received: 2001-03-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AN ADDITIONAL INDICATION, THE TREATMENT OF RESTENOSIS IN 316L STAINLESS STEEL STENTS, PRIOR TO THE ADMINISTRATION OF INTRAVASCULAR BRACHYTHERAPY, FOR THE CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM. THE INDICATION IS IN ADDITION TO THOSE LISTED IN THE FEBRUARY 19, 1993, APPROVAL LETTER.