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 DEVICE |
Generic Name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
Applicant | Spectranetics (Philips) 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P960042 |
Supplement Number | S031 |
Date Received | 09/06/2011 |
Decision Date | 04/20/2012 |
Product Code |
MFA |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR AN INCREASE IN THE MAXIMUM REPETITION RATE FROM 40 HZ TO 80 HZ OF THE SPECTRANETICS LASER SHEATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLIDELIGHT LASER SHEATH. |
Approval Order | Approval Order |
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