|
Device | FLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM) |
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 | S009 |
Date Received | 06/26/2001 |
Decision Date | 08/10/2001 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN INCREASE IN AN INTERMEDIATE SPECIFICATION FOR RESIDUAL GLUTARALDEHYDE FROM 20 TO 40 PPM, THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE INDICATIONS STATEMENT AND THE ADDITION OF THE NASAL/SINUS INSTRUCTIONS AND INORMATION TO THE LABELING OF THE "DRY" FORM OF THE FUSION MATRIX PRODUCT. |