|
Device | CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM |
Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P910001 |
Supplement Number | S023 |
Date Received | 01/31/2003 |
Decision Date | 05/02/2003 |
Product Code |
LPC |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE REVISED INSTRUCTIONS FOR USE THAT INCLUDE THE ADJUDICATED RESULTS FROM THE LARS INVESTIGATION. |