PMA P950032S036

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S036
Product code: MGR
Decision date: 2003-10-24
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: CHANGE FROM INDIVIDUAL MEDIUM COMPONENTS TO A BULK MEDIUM FORMULATION AND CHANGE IN THE METHOD OF DELIVERING THE KERATINOCYTES TO FORM A BILAYERED DERMAL-EPIDERMAL CONSTRUCT.

Current openFDA PMA Record#

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S036
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2003-10-24
Decision code: OK30
Date received: 2003-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE FROM INDIVIDUAL MEDIUM COMPONENTS TO A BULK MEDIUM FORMULATION AND CHANGE IN THE METHOD OF DELIVERING THE KERATINOCYTES TO FORM A BILAYERED DERMAL-EPIDERMAL CONSTRUCT.