Progel Pleural Air Leak Sealant
FDA premarket approval P010047/S062 · decided 2020-12-21
Approval details
- PMA number
- P010047
- Supplement
- S062
- Supplement type
- 135 Review Track For 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
- 2020-05-01
- Decision date
- 2020-12-21
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for changes to the HPLC chromatography column and test method used to evaluate the protein aggregate content in the Human Serum Albumin component of the chemistry kits contained in the PROGEL PALS and TRIDYNE VS finished devices.
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