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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceOPTIGUIDE(TM) FIBER OPTIC DIFFUSER
Generic NameSystem, laser, fiber optic, photodynamic therapy
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Dr.
Suite 210
Bannockburn, IL 60015
PMA NumberP940010
Supplement NumberS001
Date Received07/03/1996
Decision Date08/07/1996
Product Code MVG 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGE IN LABELING CONSISTING OF ADDING AN ADDITIONAL WARNING STATEMENT CONCERNING POSSIBLE LEAKAGE OF BLOOD INTO DIFFUSER CAP
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