FDA.reportPublic FDA data

PMA P840001S532

Device
Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
Applicant
Medtronic Neuromodulation
PMA number
P840001
Supplement
S532
Product code
LGW
Decision date
2022-11-22
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Add a larger facility to house the manufacturing operations of JunoPacific and Meier Toll and Engineering, which are both owned by Cretex Companies, within the same facility.

Current openFDA PMA Record#

Device
Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
Applicant
Medtronic Neuromodulation
PMA number
P840001
Supplement
S532
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2022-11-22
Decision code
OK30
Date received
2022-11-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add a larger facility to house the manufacturing operations of JunoPacific and Meier Toll and Engineering, which are both owned by Cretex Companies, within the same facility.