PMA P790002S039

Device: Biomet EBI Bone Healing System
Applicant: Ahp Eos Buyer, Inc.
PMA number: P790002
Supplement: S039
Product code: LOF
Decision date: 2023-10-26
Classification: Orthopedic
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: add a new contract service provider to provide design and development engineering services for the next generation of non-invasive electrical stimulation devices

Current openFDA PMA Record#

Device: Biomet EBI Bone Healing System
Applicant: Ahp Eos Buyer, Inc.
PMA number: P790002
Supplement: S039
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2023-10-26
Decision code: OK30
Date received: 2023-09-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: add a new contract service provider to provide design and development engineering services for the next generation of non-invasive electrical stimulation devices