BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR

FDA premarket approval P850022/S015 · decided 2004-01-12

Approval details

PMA number

P850022

Supplement

S015

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR

Generic name

Stimulator, bone growth, non-invasive

Applicant

Ahp Eos Buyer, Inc.

Date received

2003-09-30

Decision date

2004-01-12

Days to decision

104 days

Decision code

APPR

Product code

LOF

Advisory committee

Orthopedic

Expedited review

No

Location

Parsippany, NJ

Statement

APPROVAL FOR A MODIFIED VERSION OF THE BIOELECTRON SPINALPAK FUSION STIMULATOR. THE MODIFICATIONS ARE: 1) THE CURRENT SPINALPAK IS POWERED BY 1 ALKALINE 9 VOLT BATTERY THAT MUST BE REPLACED DAILY. THE MODIFIED VERSION WILL BE POWERED BY 1 NIMN "AA" RECHARGEABLE CELL. THE CHARGER WILL BE INCLUDED. 2) THE HOUSING HAS BEEN MODIFIED TO ACCOMMODATE FOR A RECHARGEABLE BATTERY AND AN LCD DISPLAY. THE CURRENT SPINALPAK HAS AN LED DISPLAY. THE MODIFIED VERSION WILL HAVE A 6 MESSAGE LCD DISPLAY. 3) THE PC