FDA.reportPublic FDA data

PMA P970004S337

Device
lnterStim Therapy System, Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S337
Product code
EZW
Decision date
2021-08-13
Generic name
Stimulator, electrical, implantable, for incontinence
Approval order statement
Change to the welding process and equipment at external supplier, Bal Seal Engineering (BSE), who supplies Radial Spring Contacts to Medtronic Energy and Component Center (MECC).

Current openFDA PMA Record#

Device
lnterStim Therapy System, Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S337
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2021-08-13
Decision code
OK30
Date received
2021-07-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the welding process and equipment at external supplier, Bal Seal Engineering (BSE), who supplies Radial Spring Contacts to Medtronic Energy and Component Center (MECC).