FDA.reportPublic FDA data

PMA P190021S006

Device
Reactiv8 Implantable Neurostimulation System
Applicant
Mainstay Medical Limited
PMA number
P190021
Supplement
S006
Product code
QLK
Decision date
2023-08-15
Classification
Neurology
Generic name
Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Approval order statement
Removal of the spot weld process for Reactiv8 Implantable Neurostimulation System’s Implantable Pulse Generator (IPG) internal battery sleeve at Centro De Construccion De Cardioestimuladores Del Uruguay S.A.

Current openFDA PMA Record#

Device
Reactiv8 Implantable Neurostimulation System
Applicant
Mainstay Medical Limited
PMA number
P190021
Supplement
S006
Product code
QLK
Generic name
Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Decision date
2023-08-15
Decision code
OK30
Date received
2023-07-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of the spot weld process for Reactiv8 Implantable Neurostimulation System’s Implantable Pulse Generator (IPG) internal battery sleeve at Centro De Construccion De Cardioestimuladores Del Uruguay S.A.