PMA P990030S001

Device: COSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT
Applicant: Angiotech Medical Device Technologies
PMA number: P990030
Supplement: S001
Product code: LMF
Decision date: 2001-01-02
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
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.

Current openFDA PMA Record#

Device: COSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT
Applicant: Angiotech Medical Device Technologies
PMA number: P990030
Supplement: S001
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2001-01-02
Decision code: APPR
Date received: 2000-10-18
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.