Progel Pleural Air Leak Sealant
FDA premarket approval P010047/S063 · decided 2021-08-17
Approval details
- PMA number
- P010047
- Supplement
- S063
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Progel Pleural Air Leak Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2020-12-22
- Decision date
- 2021-08-17
- Days to decision
- 238 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for replacing the 5mL sterile water vial with a 10mL vial
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