NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S009 · decided 2011-04-13
Approval details
- PMA number
- P010047
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2011-01-28
- Decision date
- 2011-04-13
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.
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