VITAGEL SURGICAL HEMOSTAT
FDA premarket approval P050044/S021 · decided 2013-10-11
Approval details
- PMA number
- P050044
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITAGEL SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2011-10-27
- Decision date
- 2013-10-11
- Days to decision
- 715 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- APPROVAL FOR A NEW VERSION OF VITAGEL WHERE THE BOVINE THROMBIN COMPONENT IS REPLACED WITH RECOMBINANT HUMAN THROMBIN. THE PRODUCT, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT AND IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN 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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