PROGEL Pleural Air Leak Sealant (PALS)
FDA premarket approval P010047/S054 · decided 2018-10-17
Approval details
- PMA number
- P010047
- Supplement
- S054
- 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
- 2018-01-04
- Decision date
- 2018-10-17
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for packaging modification of the subject device. The changes being made include 1) modification of the materials and process for packaging Progel PALS for shipment in order to maintain its labeled environmental condition of two to eight (2-8) degrees Celsius, 2) release a manufacturing procedure regarding how the contract manufacturer AMP is required to package and ship HSA-filled and PEG-filled cartridges to Neomend, 3) replacement of a custom-made spray tip gauge with a spray tip ref
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.