|
Device | COSTASIS(R)/DYNASTAT 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 | S001 |
Date Received | 10/18/2000 |
Decision Date | 01/02/2001 |
Withdrawal Date
|
03/07/2012 |
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 |
Approval Order Statement APPROVAL FOR A CHANGE IN THE METHOD OF TERMINAL STERILIZATION FROM E-BEAM TO GAMMA IRRADIATION AND REQUESTED AN ADDITIONAL 3-ML DELIVERY SYRINGE DEVICE WITH THE ASSOCIATED LABELING CHANGE. |