PMA P790005

Device: EBI OsteoGen® Implantable Bone Growth Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P790005
Supplement: S069
Product code: LOE
Decision date: 2022-11-23
Generic name: Stimulator, invasive bone growth
Approval order statement: Qualify an alternate contract service provider to provide calibration services for instrumentation and lab equipment utilized to support manufacturing and quality operations.

Current openFDA PMA Record#

Device: EBI OsteoGen® Implantable Bone Growth Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P790005
Supplement: S069
Product code: LOE
Generic name: Stimulator, invasive bone growth
Decision date: 2022-11-23
Decision code: OK30
Date received: 2022-10-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualify an alternate contract service provider to provide calibration services for instrumentation and lab equipment utilized to support manufacturing and quality operations.