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 | CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12 |
Generic Name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
Applicant | Spectranetics (Philips) 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P960042 |
Supplement Number | S009 |
Date Received | 04/14/2006 |
Decision Date | 08/02/2006 |
Product Code |
MFA |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A NEW SOFTWARE VERSION TO THE CVX-3000 EXCIMER LASER AND REVISED LABELING TO THE LASER CONSOLE. |
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