CELLPAKER PLASMA COLLECTION DEVICE
FDA premarket approval P050044/S019 · decided 2012-01-31
Approval details
- PMA number
- P050044
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CELLPAKER PLASMA COLLECTION DEVICE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2011-08-01
- Decision date
- 2012-01-31
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- APPROVAL FOR A DESIGN CHANGE (REMOVAL OF THE METERING KNOB) TO THE CELLPAKER COMPONENT OF THE VITAGEL SURGICAL HEMOSTAT SYSTEM, INTRODUCTION OF A NEW CONTRACT MANUFACTURER LOCATED AT TEGRA MEDICAL IN DARTHMOUTH, MASSACHUSETTS, A CHANGE TO THE PACKAGING MATERIALS AND STERILIZATION METHODS FOR THE SYSTEM COMPONENT, AND THE RE-BRANDING OF THE CELLPAKER COMPONENT AS VITAPREP PLASMA SEPARATOR.
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