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Device | SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM |
Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P910001 |
Supplement Number | S005 |
Date Received | 06/17/1993 |
Decision Date | 07/31/1995 |
Product Code |
LPC |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR VITESSE-E (MODEL 117-005) & VITESSE-E II (MODEL 117-205) CATHETERS TO BE USED WITH THE CVX-300 EXCIMER LASER SYSTEM ON ECCENTRIC LESIONS MEETING ONE OR MORE OF YOUR APPROVED INDICATIONS FOR USE |