PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S034 · decided 2015-06-17
Approval details
- PMA number
- P010047
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2014-03-07
- Decision date
- 2015-06-17
- Days to decision
- 467 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.