FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT
FDA premarket approval P990009/S026 · decided 2009-05-04
Approval details
- PMA number
- P990009
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Baxter Healthcare Corp
- Date received
- 2009-04-17
- Decision date
- 2009-05-04
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- Statement
- APPROVAL FOR INCLUSION OF TWO ADDITIONAL PRODUCT APPLICATOR TIPS TOGETHER AS PART OF THE FLOWSEAL HEMOSTATIC MATRIX KIT OR PACKAGED INDIVIDUALLY.
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