PMA P850035S052

Device: SpF Implantable Spinal Fusion Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S052
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: SpF Implantable Spinal Fusion Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S052
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.