|
Device | 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 | S001 |
Date Received | 10/04/2000 |
Decision Date | 01/22/2001 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" FOR PROCEED(TM) HEMOSTATIC SEALANT. |