NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S011 · decided 2012-05-10
Approval details
- PMA number
- P010047
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2011-05-19
- Decision date
- 2012-05-10
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF NEOMEND, INCORPORATED, IRVINE, CALIFORNIA AS A SECOND SOURCE SUPPLIER FOR THE HUMAN SERUM ALBUMIN (HSA) PROTEIN CARTRIDGES FOR THE DEVICE.
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