PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S043 · decided 2016-08-17
Approval details
- PMA number
- P010047
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2016-07-18
- Decision date
- 2016-08-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Addition of a particulate matter quality checks at various stages of the Progel manufacturing process.
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