PMA P850035S043

Device: Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S043
Product code: LOE
Decision date: 2016-11-17
Classification: Stimulator, Invasive Bone Growth
Generic name: Stimulator, invasive bone growth
Approval order statement: Approval to add the following contraindication to the labeling: Any surgical implantation procedure such as minimally invasive surgical-MIS procedures requiring the SpF® Spinal Fusion Stimulators cathodes to be disconnected from their corresponding leads prior to or during implantation since this may seriously compromise the electrical performance of the implantable stimulators cathodes to deliver a constant current to the fusion site as intended.

Current openFDA PMA Record#

Device: Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S043
Product code: LOE
Generic name: Stimulator, invasive bone growth
Decision date: 2016-11-17
Decision code: APPR
Date received: 2016-10-31
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to add the following contraindication to the labeling: Any surgical implantation procedure such as minimally invasive surgical-MIS procedures requiring the SpF® Spinal Fusion Stimulators cathodes to be disconnected from their corresponding leads prior to or during implantation since this may seriously compromise the electrical performance of the implantable stimulators cathodes to deliver a constant current to the fusion site as intended.