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Device | ELCA CORONARY ATHERECTOMY CATHETERS |
Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P910001 |
Supplement Number | S047 |
Date Received | 05/09/2011 |
Decision Date | 01/13/2012 |
Product Code |
LPC |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED IN COLORADO SPRINGS, COLORADO. |