PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S026 · decided 2013-07-25
Approval details
- PMA number
- P010047
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2012-11-20
- Decision date
- 2013-07-25
- Days to decision
- 247 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- 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.
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