PROGEL Pleural Air Leak Sealant (PALS)
FDA premarket approval P010047/S046 · decided 2018-07-03
Approval details
- PMA number
- P010047
- Supplement
- S046
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROGEL Pleural Air Leak Sealant (PALS)
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2017-08-28
- Decision date
- 2018-07-03
- Days to decision
- 309 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for manufacturing changes regarding the silicone concentration and application methods to the glass cartridges containing the chemical pre-gel components of the PROGEL Pleural Air Leak Sealant (PALS) device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.