Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: PROGEL PLEURAL AIR LEAK SEALANT
• Generic Name: Sealant, polymerizing
• Applicant: NEOMEND, INC.; 60 TECHNOLOGY DR.; IRVINE, CA 92618
• PMA Number: P010047
• Date Received: 08/23/2001
• Decision Date: 01/14/2010
• Product Code: NBE
• Docket Number: 10M-0068
• Notice Date: 01/27/2010
• Advisory Committee: Anesthesiology
• Expedited Review Granted?: No
• Combination Product: Yes
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR PROGEL PLEURAL AIR LEAK SEALANT. THE DEVICE IS INDICATED FOR APPLICATION TO VISCERAL PLEURA DURING AN OPEN THORACOTOMY AFTER STANDARD VISCERAL PLEURAL CLOSURE WITH, FOR EXAMPLE, SUTURES OR STAPLES, OF VISIBLE AIR LEAKS (>=2 MM) INCURRED DURING OPEN RESECTION OF LUNG PARENCHYMA.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S013 ; S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S026 ; S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S039 ; S040 S041 S042 S043 S044 S046 S047 S048 S049 S050 S051 S053 ; S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 ; S066 S067 S068 S069