PMA P910066S028

Device: OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S028
Product code: LOF
Decision date: 2016-02-18
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Approval for the labeling to be in conformance with IEC 60601-1-6 ED.3.1, IEC 60601-1-2, ANSI/AAMI ES 60601-1:2005/A1:2012 and IEC 60601-11:2011.

Current openFDA PMA Record#

Device: OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S028
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2016-02-18
Decision code: APPR
Date received: 2016-01-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the labeling to be in conformance with IEC 60601-1-6 ED.3.1, IEC 60601-1-2, ANSI/AAMI ES 60601-1:2005/A1:2012 and IEC 60601-11:2011.