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 | S022 |
Date Received | 08/20/2012 |
Decision Date | 04/04/2013 |
Product Code |
NBE |
Advisory Committee |
Anesthesiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGE TO A RESIN SUPPLIER. |
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