FDA.reportPublic FDA data

PMA P850035S055

Device
SpF Implantable Spinal Fusion Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P850035
Supplement
S055
Product code
LOE
Decision date
2019-07-18
Classification
Stimulator, Invasive Bone Growth
Generic name
Stimulator, invasive bone growth
Approval order statement
Qualify and approve an alternate, proposed supplier, Vesta Intermediate Funding d/b/a Lubrizol Life Sciences to provide a silicone over-extruded cable to manufacture and assemble implantable stimulator leads for the subject devices (OsteoGen Surigically Implantable Bone Growth Stimulators and SpF Implantable Spinal Fusion Stimulators).

Current openFDA PMA Record#

Device
SpF Implantable Spinal Fusion Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P850035
Supplement
S055
Product code
LOE
Generic name
Stimulator, invasive bone growth
Decision date
2019-07-18
Decision code
OK30
Date received
2019-06-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Qualify and approve an alternate, proposed supplier, Vesta Intermediate Funding d/b/a Lubrizol Life Sciences to provide a silicone over-extruded cable to manufacture and assemble implantable stimulator leads for the subject devices (OsteoGen Surigically Implantable Bone Growth Stimulators and SpF Implantable Spinal Fusion Stimulators).