Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Straumann Emdogain
• Generic Name: Biologic material, dental
• Regulation Number: 872.3930
• Applicant: The Straumann Company; 60 Minuteman Rd.; Andover, MA 01810
• PMA Number: P930021
• Supplement Number: S018
• Date Received: 12/15/2017
• Decision Date: 09/28/2018
• Product Code: NQA
• Advisory Committee: Dental
• Supplement Type: 135 Review Track For 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

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.