PROGEL PLEURAL AIR LEAK SEALANT DEVICE
FDA premarket approval P010047/S019 · decided 2012-08-23
Approval details
- PMA number
- P010047
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT DEVICE
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2012-04-06
- Decision date
- 2012-08-23
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN EXTENSION OF THE REFRIGERATED SHELF LIFE OF THE DEVICE.
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