NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S005 · decided 2010-12-29
Approval details
- PMA number
- P010047
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2010-08-11
- Decision date
- 2010-12-29
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF A SECOND MANUFACTURING SOURCE FOR A CRITICAL DEVICE COMPONENT.
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