PMA P850035S044

Device: SpF Implantable Spinal Fusion Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S044
Product code: LOE
Decision date: 2017-03-27
Generic name: Stimulator, invasive bone growth
Approval order statement: Alternate water supplier to conduct device-specific, manufacturing final washing operations when the existing, deionized water produced is unavailable due to preventive maintenance activities.

Current openFDA PMA Record#

Device: SpF Implantable Spinal Fusion Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S044
Product code: LOE
Generic name: Stimulator, invasive bone growth
Decision date: 2017-03-27
Decision code: OK30
Date received: 2017-03-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate water supplier to conduct device-specific, manufacturing final washing operations when the existing, deionized water produced is unavailable due to preventive maintenance activities.