PMA P910066S016

Device: OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S016
Product code: LOF
Decision date: 2001-05-18
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL TO: 1)REFORMAT THE PATIENT MANUALS FOR THE OL 1000 AND OL 1000 SC BONE GROWTH STIMULATORS PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING, 2) REFORMAT THE PATIENT MANUAL FOR THE SPINALOGIC(TM) BONE GROWTH STIMULATOR PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING.

Current openFDA PMA Record#

Device: OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S016
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2001-05-18
Decision code: APPR
Date received: 2001-04-11
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO: 1)REFORMAT THE PATIENT MANUALS FOR THE OL 1000 AND OL 1000 SC BONE GROWTH STIMULATORS PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING, 2) REFORMAT THE PATIENT MANUAL FOR THE SPINALOGIC(TM) BONE GROWTH STIMULATOR PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING.