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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.
 
DevicePROGEL PLEURAL LEAK SEALANT
Generic NameSealant, polymerizing
ApplicantNEOMEND, INC.
60 TECHNOLOGY DR.
IRVINE, CA 92618
PMA NumberP010047
Supplement NumberS016
Date Received01/30/2012
Decision Date03/23/2012
Product Code NBE 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR AN EXTENSION OF SHELF LIFE OF THE PROGEL EXTENDED APPLICATOR SPRAY TIPS FORM 12 TO 24 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROGEL EXTENDED APPLICATOR SPRAY TIPS AND IS INDICATED TO DELIVER PROGEL TO VISCERAL PLEURA DURING AN OPEN THORACOTOMY AFTER STANDARD VISCERAL PLEURAL CLOSURE (I.E. WITH SUTURES OR STAPLES) OF VISIBLE AIR LEAKS (>= 2 MM) INCURRED DURING OPEN RESECTION OF LUNG PARENCHYMA IN ADULT HUMANS BY BENDING THE MALLEABLE TIP TO DIRECT PROGEL FROM THE DELIVERY TIP IN A STREAM OR SPRAY CONE PATTERN THAT IS PERPENDICULAR TO THETARGET SURFACE.
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