PMA P050044S019
- Device
- CELLPAKER PLASMA COLLECTION DEVICE
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S019
- Product code
- LMF
- Decision date
- 2012-01-31
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order 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.
Current openFDA PMA Record#
- Device
- CELLPAKER PLASMA COLLECTION DEVICE
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S019
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2012-01-31
- Decision code
- APPR
- Date received
- 2011-08-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.