|
Device | PROGEL PLEURAL AIR LEAK SEALANT |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P010047 |
Supplement Number | S034 |
Date Received | 03/07/2014 |
Decision Date | 06/17/2015 |
Product Code |
NBE |
Advisory Committee |
Anesthesiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFYING THE STORAGE CONDITIONS OF PROGEL PLEURAL AIR LEAK. THE INCLUSION OF A CONSECUTIVE OR CUMULATIVE CONTROLLED ROOM TEMPERATURE STORAGE EXCURSION OF 8 °C TO 25 °C FOR A PERIOD UP TO 35 DAYS WITHIN THE APPROVED 24-MONTH SHELF LIFE WHEN THE DEVICE IS NORMALLY STORED BETWEEN 2 °C TO 8°C. |
Post-Approval Study | Show Report Schedule and Study Progress |