PMA P010047S054

Device

PROGEL Pleural Air Leak Sealant (PALS)

Applicant

Neomend, Inc.

PMA number

P010047

Supplement

S054

Product code

NBE

Decision date

2018-10-17

Classification

Sealant, Polymerizing

Generic name

Sealant, polymerizing

Approval order statement

Approval for packaging modification of the subject device. The changes being made include 1) modification of the materials and process for packaging Progel PALS for shipment in order to maintain its labeled environmental condition of two to eight (2-8) degrees Celsius, 2) release a manufacturing procedure regarding how the contract manufacturer AMP is required to package and ship HSA-filled and PEG-filled cartridges to Neomend, 3) replacement of a custom-made spray tip gauge with a spray tip reference aid to confirm set up of the Uson Sprint LC multi-leak air tester, and 4) modification of the Freeze Watch indicator.”

Summary

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