PMA P990030S002
- Device
- COSTASIS/DYNASTAT SURGICAL HEMOSTAT
- Applicant
- Angiotech Medical Device Technologies
- PMA number
- P990030
- Supplement
- S002
- Product code
- LMF
- Decision date
- 2001-12-21
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE COSTASIS(R)/DYNASTAT(TM) SURGICAL HEMOSTATS' PRODUCT LABELING.
Current openFDA PMA Record#
- Device
- COSTASIS/DYNASTAT SURGICAL HEMOSTAT
- Applicant
- Angiotech Medical Device Technologies
- PMA number
- P990030
- Supplement
- S002
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2001-12-21
- Decision code
- APPR
- Date received
- 2001-11-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE COSTASIS(R)/DYNASTAT(TM) SURGICAL HEMOSTATS' PRODUCT LABELING.