VITAGEL RT3 SUTGICAL HEMOSTAT
FDA premarket approval P050044 · decided 2006-06-16
Approval details
- PMA number
- P050044
- Trade name
- VITAGEL RT3 SUTGICAL HEMOSTAT
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Applicant
- Stryker Corp.
- Date received
- 2005-11-30
- Decision date
- 2006-06-16
- Days to decision
- 198 days
- Decision code
- APWD
- Product code
- PMX
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- APPROVAL FOR THE VITAGEL SURGICAL HEMOSTAT. THE DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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