PMA P850007S032

Device
PHYSIO-STIM & SPINAL-STIM
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S032
Product code
LOF
Decision date
2011-11-02
Classification
Stimulator, Bone Growth, Non-invasive
Generic name
Stimulator, bone growth, non-invasive
Approval order statement
ADDITION OF AN ALTERNATE BATTERY PACK SUPPLIER.

Current openFDA PMA Record#

Device
PHYSIO-STIM & SPINAL-STIM
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S032
Product code
LOF
Generic name
Stimulator, bone growth, non-invasive
Decision date
2011-11-02
Decision code
OK30
Date received
2011-10-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN ALTERNATE BATTERY PACK SUPPLIER.