FDA.reportPublic FDA data

PMA P970004S333

Device
InterStim Therapy System and Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S333
Product code
EZW
Decision date
2021-06-22
Generic name
Stimulator, electrical, implantable, for incontinence
Approval order statement
Update the connector assembly resistance spot welding process window for the InterStim Micro INS (model 97810) at the Medtronic’s manufacturing facility located in Juncos, Puerto Rico.

Current openFDA PMA Record#

Device
InterStim Therapy System and Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S333
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2021-06-22
Decision code
OK30
Date received
2021-05-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update the connector assembly resistance spot welding process window for the InterStim Micro INS (model 97810) at the Medtronic’s manufacturing facility located in Juncos, Puerto Rico.