PMA P930021S018

Device: Straumann Emdogain
Applicant: The Straumann Company
PMA number: P930021
Supplement: S018
Product code: NQA
Decision date: 2018-09-28
Classification: Biologic Material, Dental
Generic name: Biologic material, dental
Approval order statement: Approval for: 1) Revision of ventilation and implementation of cooling in clean rooms;2) Emdogain bulk tank will be covered by a sterile autoclave bag during storage time between compounding and filling;3) Implementation of heat-sealed autoclave pouch for sterilization and storage of stopper hopper;4) The sterile phase of the P2R2 autoclave program, validated for sterilization of filters and other equipment used for aseptic production, was increased from 20 to 25 min;5) Sampling and weighing method of the PGA has been changed to be conducted in plastic Nalgene bottles; 6) The rules for analysis and reference sampling for each sub batch of Emdogain were updated to reduce the overall number of samples taken per day;7) Specifications for nitrogen gas and compressed air were updated; and8) An alternative IPC method (IR spectroscopy) for protein content determination in Emdogain process intermediates has been validated and implemented.

Current openFDA PMA Record#

Device: Straumann Emdogain
Applicant: The Straumann Company
PMA number: P930021
Supplement: S018
Product code: NQA
Generic name: Biologic material, dental
Decision date: 2018-09-28
Decision code: APPR
Date received: 2017-12-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for: 1) Revision of ventilation and implementation of cooling in clean rooms;2) Emdogain bulk tank will be covered by a sterile autoclave bag during storage time between compounding and filling;3) Implementation of heat-sealed autoclave pouch for sterilization and storage of stopper hopper;4) The sterile phase of the P2R2 autoclave program, validated for sterilization of filters and other equipment used for aseptic production, was increased from 20 to 25 min;5) Sampling and weighing method of the PGA has been changed to be conducted in plastic Nalgene bottles; 6) The rules for analysis and reference sampling for each sub batch of Emdogain were updated to reduce the overall number of samples taken per day;7) Specifications for nitrogen gas and compressed air were updated; and8) An alternative IPC method (IR spectroscopy) for protein content determination in Emdogain process intermediates has been validated and implemented.