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 LASER SHEATH (SLS, SLS II, AND GLIDELIGHT) |
Generic Name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
Applicant | Spectranetics (Philips) 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P960042 |
Supplement Number | S049 |
Date Received | 07/14/2014 |
Decision Date | 10/09/2014 |
Product Code |
MFA |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR PARAMETRIC RELEASE FOR THE EXCIMER LASER CORONARY ATHERECTOMY CATHETER AND SPECTRANETICS LASER SHEATH KITS. |
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