FDA.reportPublic FDA data

PMA P970004S336

Device
InterStim Therapy System, Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S336
Product code
EZW
Decision date
2021-07-15
Generic name
Stimulator, electrical, implantable, for incontinence
Approval order statement
Use additional existing sealer tray machines and to update applicable procedures to include validated sealing and peel strength testing parameters on the Sterile Pack Manufacturing Line.

Current openFDA PMA Record#

Device
InterStim Therapy System, Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S336
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2021-07-15
Decision code
OK30
Date received
2021-07-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use additional existing sealer tray machines and to update applicable procedures to include validated sealing and peel strength testing parameters on the Sterile Pack Manufacturing Line.