FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
FDA premarket approval P990009 · decided 1999-12-08
Approval details
- PMA number
- P990009
- Trade name
- FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Applicant
- Baxter Healthcare Corp
- Date received
- 1999-02-22
- Decision date
- 1999-12-08
- Days to decision
- 289 days
- Decision code
- APPR
- Product code
- PMX
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- Statement
- THE DEVICE IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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