| 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. |
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| Device | PROGEL Pleural Air Leak Sealant (PALS) |
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| Generic Name | Sealant, polymerizing |
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| Applicant | Neomend, Inc.
60 Technology Dr.
Irvine, CA 92618 |
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| PMA Number | P010047 |
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| Supplement Number | S054 |
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| Date Received | 01/04/2018 |
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| Decision Date | 10/17/2018 |
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| Product Code |
NBE |
| Advisory Committee |
Anesthesiology |
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| Supplement Type | 135 Review Track For 30-Day Notice |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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.” |
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