Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | SPECTRANETICS 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 | S026 |
Date Received | 11/16/2006 |
Decision Date | 05/11/2007 |
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 THE REMOVAL OF A COATING ON THE INNER LUMEN OF THE EXTREME CATHETER MODEL NUMBERS 114-001, 117-002, AND 120-001, THE CHANGE TO BLACK TUBING FOR 0.9 MM CATHETER MODEL NUMBERS 110-003 AND 110-004 X-80, AND THE CHANGE IN THE STRAIN RELIEF MATERIAL DUROMETER FOR THE 0.9 MM EXTREME CATHETER MODEL NUMBERS 110-001, 110-002, 110-152 AND 0.7 MM EXTREME CATHETER MODEL 110-005 TO PREVENT KINKING AT THE STRAIN RELIEF. |
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