FDA.reportPublic FDA data

PMA P970004S349

Device
Master InterStim Therapy System, Verify Evaluation System
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S349
Product code
EZW
Decision date
2021-12-08
Generic name
Stimulator, electrical, implantable, for incontinence
Approval order statement
Approval for revisions to physician and patient labeling to align with updated risk management process. The labeling changes include existing precautions elevated to warnings for packaging, single use and effects on other implanted devices.

Current openFDA PMA Record#

Device
Master InterStim Therapy System, Verify Evaluation System
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S349
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2021-12-08
Decision code
APPR
Date received
2021-11-16
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revisions to physician and patient labeling to align with updated risk management process. The labeling changes include existing precautions elevated to warnings for packaging, single use and effects on other implanted devices.