FDA.reportPublic FDA data

PMA P790005S065

Device
EBI OsteoGen Implantable Bone Growth Stimulators
Applicant
Ahp Eos Buyer, Inc.
Product code
LOE
Decision date
2019-10-24
Generic name
Stimulator, invasive bone growth
Approval order statement
Approval to qualify and place into service an upgraded and redesigned Reverse Osmosis, Deionized (RO/DI) Water System along with its ancillary equipment and components at Zimmer Biomets, EBI Patient Care, Guaynabo, Puerto Rico Manufacturing and Distribution Facility.

Current openFDA PMA Record#

Device
EBI OsteoGen Implantable Bone Growth Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P790005
Supplement
S065
Product code
LOE
Generic name
Stimulator, invasive bone growth
Decision date
2019-10-24
Decision code
APPR
Date received
2018-12-14
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval to qualify and place into service an upgraded and redesigned Reverse Osmosis, Deionized (RO/DI) Water System along with its ancillary equipment and components at Zimmer Biomets, EBI Patient Care, Guaynabo, Puerto Rico Manufacturing and Distribution Facility.