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Device | PROGEL PLEURAL AIR LEAK SEALANT AND PROGEL EXTENDED APPLICATOR SPRAY TIP |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P010047 |
Supplement Number | S037 |
Date Received | 03/02/2015 |
Decision Date | 03/16/2015 |
Product Code |
NBE |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO EXTEND ENROLLMENT BY 13 MONTHS TO COMPLETE ENROLLMENT IN THE PAS TO THE POST-APPROVAL STUDY PROTOCOL. |
Post-Approval Study | Show Report Schedule and Study Progress |