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. |
|
Device | PROGEL PLEURAL AIR LEAK SEALANT |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P010047 |
Supplement Number | S026 |
Date Received | 11/20/2012 |
Decision Date | 07/25/2013 |
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 A CHANGE IN THE SHIPPING TEMPERATURE RANGE TO 1ºC TO 30°C TO ALLOW FOR BRIEF POSSIBLE EXTREMES IN TEMPERATURE DURING SHIPMENT. THE AGENCY NOTES THAT THE "KEEP REFRIGERATED" LABEL, C-00473, WILL BE AFFIXED TO THE SHIPPING CONTAINER. |
|
|