PROGEL Pleural Air Leak Sealant
FDA premarket approval P010047/S065 · decided 2022-02-09
Approval details
- PMA number
- P010047
- Supplement
- S065
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- PROGEL Pleural Air Leak Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2021-03-02
- Decision date
- 2022-02-09
- Days to decision
- 344 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for labeling changes.
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