|
Device | VITAGEL SURGICAL HEMOSTAT |
Generic Name | Absorbable collagen hemostatic agent with thrombin |
Regulation Number | 878.4490 |
Applicant | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES 3600 S.W 47TH AVENUE GAINESVILLE, FL 32608 |
PMA Number | P990030 |
Date Received | 06/07/1999 |
Decision Date | 06/13/2000 |
Withdrawal Date
|
03/07/2012 |
Product Code |
PMX |
Docket Number | 00M-1368 |
Notice Date | 07/12/2000 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR COSTASIS(R) SURGICAL HEMOSTAT AND DYNASTAT(TM) SURGICAL HEMOSTAT. THIS DEVICE IS INDICATED FOR USE 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
|
Supplements: |
S001 S002 S003 S004 S005 |