COSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT
FDA premarket approval P990030/S001 · decided 2001-01-02
Approval details
- PMA number
- P990030
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Angiotech Medical Device Technologies
- Date received
- 2000-10-18
- Decision date
- 2001-01-02
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Gainesville, FL
- 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.
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