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Device | FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT |
Generic Name | Absorbable collagen hemostatic agent with thrombin |
Regulation Number | 878.4490 |
Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD ROUND LAKE, IL 60073 |
PMA Number | P990009 |
Date Received | 02/22/1999 |
Decision Date | 12/08/1999 |
Product Code |
PMX |
Docket Number | 00M-1229 |
Notice Date | 12/08/1999 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement THE DEVICE IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S048 S049 S050 S051 S052 S053 S054 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S067 S068 S069 S070 S071 S072 S073 |