|
Device | FLOSEAL MATRIX/MATRIX HEMOSTATIC SEALANT/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 | S006 |
Date Received | 03/02/2001 |
Decision Date | 04/30/2001 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF LANGUAGE TO THE PACKAGE INSERT REGARDING THE USE OF FLOSEAL(R) MATRIX AND PROCEED(TM) HEMOSTATIC SEALANTS AS AGENTS FOR NASAL/SINUS BLEEDING. |