PROGEL PLEURAL AIR LEAK SEALANT WITH RECOMBINANT HUMAN ALBUMIN
FDA premarket approval P010047/S032 · decided 2016-04-15
Approval details
- PMA number
- P010047
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT WITH RECOMBINANT HUMAN ALBUMIN
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2013-12-30
- Decision date
- 2016-04-15
- Days to decision
- 837 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval to add a model that changes the source material for the protein solution from Human Serum Albumin (HSA) to recombinant Human Albumin (rHA for the Progel® Pleural Air Leak Sealant (PALS) with Recombinant Human Albumin (rHA) .
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.