- Device
- SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S001
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 1996-11-07
- Decision code
- APPR
- Date received
- 1996-10-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- CHANGE IN THE CURRENT HA/CMC SPECIFICATION FOR THE UREA ASSAY FROM THE CURRENT 3 - 15% TO A SPECIFICATION OF 10-18% FOR THE MODIFIED ASSAY. THE SUPPLEMENT ALSO REQUESTS THE REPLACEMENT OF THE USP RABBIT PYROGEN ASSAY WITH THE LIMULUS AMOEBOCYTE LYSATE (LAL) ASSAY AS THE STANDARD PYROGEN TEST