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 KITS, 14FR AND 16FR |
Applicant | Spectranetics (Philips) 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P960042 |
Supplement Number | S004 |
Date Received | 02/17/1999 |
Decision Date | 08/03/1999 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a 2-year shelf life for the 14 Fr and 16 Fr Laser Sheath Kits. |
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