|
Device | VITAGEL SURGICAL HEMOSTAT |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES 3600 S.W 47TH AVENUE GAINESVILLE, FL 32608 |
PMA Number | P990030 |
Supplement Number | S005 |
Date Received | 08/23/2004 |
Decision Date | 09/13/2004 |
Withdrawal Date
|
03/07/2012 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW TRADE NAME FOR THE DEVICE PREVIOUSLY KNOWN AS THE COSTASIS/DYNASTAT SURGICAL HEMOSTAT: THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL SURGICAL HEMOSTAT AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL. |