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 |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P010047 |
Supplement Number | S065 |
Date Received | 03/02/2021 |
Decision Date | 02/09/2022 |
Product Code |
NBE |
Advisory Committee |
Anesthesiology |
Clinical Trials | NCT01394978
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Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for labeling changes. |
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