PMA P950032S044

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S044
Product code: MGR
Decision date: 2007-07-13
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: APPROVAL FOR A NEW CELL STRAIN, HEP 040, FOR INTRODUCTION INTO PRODUCTION OF APLIGRAF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APLIGRAF AND IS INDICATED FOR THE TREATMENT OF PARTIAL AND FULL THICKNESS CHRONIC VENOUS ULCERS.

Current openFDA PMA Record#

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S044
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2007-07-13
Decision code: APPR
Date received: 2007-05-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW CELL STRAIN, HEP 040, FOR INTRODUCTION INTO PRODUCTION OF APLIGRAF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APLIGRAF AND IS INDICATED FOR THE TREATMENT OF PARTIAL AND FULL THICKNESS CHRONIC VENOUS ULCERS.