Progel Pleural Air Leak Sealant (Progel PALS)
FDA premarket approval P010047/S064 · decided 2021-02-11
Approval details
- PMA number
- P010047
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Progel Pleural Air Leak Sealant (Progel PALS)
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2021-01-14
- Decision date
- 2021-02-11
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Addition of an equivalent piece of testing equipment utilized in a lot release test.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.