|
Device | FLOSEAL MATRIX (AKA PROCEED) HEMOSTATIC SEALANT |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD ROUND LAKE, IL 60073 |
PMA Number | P990009 |
Supplement Number | S004 |
Date Received | 01/16/2001 |
Decision Date | 02/28/2001 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN INCREASE IN AN INTERMEDIATE SPECIFICATION FOR RESIDUAL GLUTARALDEHYDE FROM 20 TO 40 PPM. |