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 | NEOMEND PROGEL PLEURAL AIR LEAK SEALANT |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P010047 |
Supplement Number | S011 |
Date Received | 05/19/2011 |
Decision Date | 05/10/2012 |
Product Code |
NBE |
Advisory Committee |
Anesthesiology |
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 THE ADDITION OF NEOMEND, INCORPORATED, IRVINE, CALIFORNIA AS A SECOND SOURCE SUPPLIER FOR THE HUMAN SERUM ALBUMIN (HSA) PROTEIN CARTRIDGES FOR THE DEVICE. |
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