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 | S063 |
Date Received | 12/22/2020 |
Decision Date | 08/17/2021 |
Product Code |
NBE |
Advisory Committee |
Anesthesiology |
Clinical Trials | NCT01959503
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for replacing the 5mL sterile water vial with a 10mL vial |
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