PROGEL Pleural Air Leak Sealant
FDA premarket approval P010047/S072 · decided 2025-12-18
Approval details
- PMA number
- P010047
- Supplement
- S072
- 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
- 2025-11-26
- Decision date
- 2025-12-18
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- to reduce the testing frequencies of three tests for the TRIDYNE Vascular Sealant and the PROGEL Pleural Air Leak Sealant
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.