PROGEL Pleural Air Leak Sealant
FDA premarket approval P010047/S070 · decided 2025-05-09
Approval details
- PMA number
- P010047
- Supplement
- S070
- 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
- 2025-04-11
- Decision date
- 2025-05-09
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- reinstatement of quarterly dose auditing for the chemistry kit component of the PROGEL and TRIDYNE sealant products
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