FDA.reportPublic FDA data

PMA P790005S063

Device
EBI OsteoGen Impantable Bone Growth Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P790005
Supplement
S063
Product code
LOE
Decision date
2018-05-04
Classification
Stimulator, Invasive Bone Growth
Generic name
Stimulator, invasive bone growth
Approval order statement
Modifying and upgrading the Compressed Contact Air Utility System to replace the existing, legacy, compressed contact air system to conform to the company's newly adopted global engineering specification.

Current openFDA PMA Record#

Device
EBI OsteoGen Impantable Bone Growth Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P790005
Supplement
S063
Product code
LOE
Generic name
Stimulator, invasive bone growth
Decision date
2018-05-04
Decision code
OK30
Date received
2018-04-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modifying and upgrading the Compressed Contact Air Utility System to replace the existing, legacy, compressed contact air system to conform to the company's newly adopted global engineering specification.