FLOSEAL MATRIX HEMOSTATIC AGENT FLOSEAL ENDOSCOPIC APPLICATOR
FDA premarket approval P990009/S016 · decided 2005-03-31
Approval details
- PMA number
- P990009
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FLOSEAL MATRIX HEMOSTATIC AGENT FLOSEAL ENDOSCOPIC APPLICATOR
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Baxter Healthcare Corp
- Date received
- 2004-11-15
- Decision date
- 2005-03-31
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- Statement
- APPROVAL FOR A MODIFICATION TO THE ENDOSCOPIC APPLICATOR AND A MODIFICATION OF THE "INDICATION FOR USE" FOR THE ENDOSCOPIC APPLICATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL ENDOSCOPIC APPLICATOR AND IS INDICATED FOR USE IN DELIVERING FLOSEAL MATRIX HEMOSTATIC SEALANT TO BLEEDING SURGICAL SITES THROUGH A 5 MM OR LARGER TROCAR.
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