PMA P950032S024

Device: APLIGRAF/GRAFTSKIN
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S024
Product code: MGR
Decision date: 2001-07-16
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: CHANGE TO USE AN ADDITIONAL SHIPPING CONTAINER FOR THE APLIGRAF(TM) DEVICE THAT WOULD MAINTAIN PRODUCT INTEGRITY FOR A PERIOD OF 72 HOURS. THE CHANGE WILL ALLOW FOR GREATER FLEXIBILITY WITH DOMESTIC SHIPMENTS BY ENSURING PRODUCT INTEGRITY FOR A LONGER PERIOD, AND REDUUCE WASTE.

Current openFDA PMA Record#

Device: APLIGRAF/GRAFTSKIN
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S024
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2001-07-16
Decision code: OK30
Date received: 2001-06-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO USE AN ADDITIONAL SHIPPING CONTAINER FOR THE APLIGRAF(TM) DEVICE THAT WOULD MAINTAIN PRODUCT INTEGRITY FOR A PERIOD OF 72 HOURS. THE CHANGE WILL ALLOW FOR GREATER FLEXIBILITY WITH DOMESTIC SHIPMENTS BY ENSURING PRODUCT INTEGRITY FOR A LONGER PERIOD, AND REDUUCE WASTE.