PMA P950032S001

Device: APLIGRAF (GRAFTSKIN)
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S001
Product code: MGR
Decision date: 1998-07-09
Generic name: Dressing, wound and burn, interactive
Approval order statement: The 30-day Notice requested a manufacturing process change fro Apligraf(TM). The requested change will replace 8 laboratory-scale incubators currently used in the Apligraf(TM) manufacturing process, FORMA Steri-Cult 200, model #3033, with 6 production-scale incubators manufactured by Lunaire Corporation (model # CI0641W-6SPL). The change will require a lower temperature setpoint in the Lunaire incubators during manufacturing.

Current openFDA PMA Record#

Device: APLIGRAF (GRAFTSKIN)
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S001
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 1998-07-09
Decision code: OK30
Date received: 1998-06-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day Notice requested a manufacturing process change fro Apligraf(TM). The requested change will replace 8 laboratory-scale incubators currently used in the Apligraf(TM) manufacturing process, FORMA Steri-Cult 200, model #3033, with 6 production-scale incubators manufactured by Lunaire Corporation (model # CI0641W-6SPL). The change will require a lower temperature setpoint in the Lunaire incubators during manufacturing.