PMA P950032S072

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S072
Product code: MGR
Decision date: 2013-07-11
Generic name: Dressing, wound and burn, interactive
Approval order statement: APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELLSTRAIN 197 (HEP 197) FOR USE IN THE MANUFACTURE OF APLIGRAF, AND FOR APPROVAL OF A CHANGE FROM THE CURRENT TEST ASSAY FOR DETECTION OF CERTAIN VIRAL CONTAMINANTS TO A REAL-TIME PCR METHOD FROM A CONVENTIONAL GEL-BASED PCR METHOD.

Current openFDA PMA Record#

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S072
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2013-07-11
Decision code: APPR
Date received: 2013-04-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELLSTRAIN 197 (HEP 197) FOR USE IN THE MANUFACTURE OF APLIGRAF, AND FOR APPROVAL OF A CHANGE FROM THE CURRENT TEST ASSAY FOR DETECTION OF CERTAIN VIRAL CONTAMINANTS TO A REAL-TIME PCR METHOD FROM A CONVENTIONAL GEL-BASED PCR METHOD.