Premarket Approval (PMA)

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.

• Device: PROGEL Pleural Air Leak Sealant
• Generic Name: Sealant, polymerizing
• Applicant: Neomend, Inc.; 60 Technology Dr.; Irvine, CA 92618
• PMA Number: P010047
• Supplement Number: S067
• Date Received: 08/08/2022
• Decision Date: 09/06/2022
• Product Code: NBE
• Advisory Committee: Anesthesiology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Relocation of the Glass Cartridge Syringe Manufacturing site.