- Device
- EBI OsteoGen™ Implantable Bone Growth Stimulators
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P790005
- Supplement
- S068
- Product code
- LOE
- Generic name
- Stimulator, invasive bone growth
- Decision date
- 2022-08-25
- Decision code
- APPR
- Date received
- 2022-05-27
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for executing an ethylene oxide terminal sterilization process validation to align with applicable requirements of ISO 11135:2014 (14-529).