FDA.reportPublic FDA data

PMA P970004S307

Device
InterStim Therapy System, Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S307
Product code
EZW
Decision date
2020-02-05
Generic name
Stimulator, electrical, implantable, for incontinence
Approval order statement
Change in the destructive testing pull test sampling, sampling frequency, and tightening of the control limits established for the pull test monitoring.

Current openFDA PMA Record#

Device
InterStim Therapy System, Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S307
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2020-02-05
Decision code
OK30
Date received
2020-01-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the destructive testing pull test sampling, sampling frequency, and tightening of the control limits established for the pull test monitoring.