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 | KARL STORZ AUTOFLUORESCENCE SYSTEM |
Generic Name | SYSTEM, IMAGING, FLUORESCENCE |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE CULVER CITY, CA 90230-7600 |
PMA Number | P020008 |
Supplement Number | S002 |
Date Received | 10/22/2009 |
Decision Date | 12/23/2009 |
Withdrawal Date
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08/28/2019 |
Product Code |
MRK |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REPLACEMENT OF THE KARL STORZ CAMERA CONTROL UNIT (CCU), TRICAM SL (ANALOG PROCESSING) WITH THE TRICAM SL II (DIGITAL SIGNAL PROCESSING). |
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