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 | S042 |
Date Received | 12/28/2015 |
Decision Date | 01/26/2016 |
Product Code |
NBE |
Advisory Committee |
Anesthesiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL OF ALTERNATE SUPPLIERS OF TESTING REAGENTS USED FOR ANALYTICAL TESTING (I.E., THE BIURET TEST REAGENT AND PROTEIN PRIMARY STANDARD) OF THE TOTAL PROTEIN CONTENT OF THE HUMAN SERUM ALBUMIN (HAS) COMPONENT OF THE PROGEL PALS FINISHED DEVICE. |
Post-Approval Study | Show Report Schedule and Study Progress |
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