VITAPREP PLASMA SEPERATOR
FDA premarket approval P050044/S023 · decided 2012-09-25
Approval details
- PMA number
- P050044
- Supplement
- S023
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITAPREP PLASMA SEPERATOR
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2012-08-29
- Decision date
- 2012-09-25
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- APPROVAL FOR THE FOLLOWING TWO CHANGES TO THE LABELING INSTRUCTIONS FOR USE FOR THE VITAPREP PLASMA SEPARATOR: 1) INCLUSION OF WARNING STATEMENT: "ALWAYS WEAR WELL FITTING GLOVES WHEN HANDLING VITAPREP¿ AND 2) INCLUSION OF INSTRUCTIONS: "ASSURE THERE IS NO BLOOD IN THE LUER CONNECTION. IF BLOOD IS PRESENT, CAREFULLY CLEAR THE AREA OF RESIDUAL BLOOD.¿
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