|
Device | CELLPAKER PLASMA COLLECTION DEVICE |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | STRYKER CORP. 2825 AIRVIEW BOULEVARD PORTAGE, MI 49002 |
PMA Number | P050044 |
Supplement Number | S019 |
Date Received | 08/01/2011 |
Decision Date | 01/31/2012 |
Withdrawal Date
|
07/10/2019 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
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. |
Approval Order | Approval Order |