FDA.reportPublic FDA data

PMA P970004S309

Device
InterStim Therapy System and Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S309
Product code
EZW
Decision date
2020-05-07
Generic name
Stimulator, electrical, implantable, for incontinence
Approval order statement
Change requested to update the existing Soft Straight-Line Finish (SLF) cosmetic rework process at the Medtronic Puerto Rico Operations Company (MPROC), located in Juncos, Puerto Rico. The change also requested other related minor documentation updates .

Current openFDA PMA Record#

Device
InterStim Therapy System and Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S309
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2020-05-07
Decision code
OK30
Date received
2020-04-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change requested to update the existing Soft Straight-Line Finish (SLF) cosmetic rework process at the Medtronic Puerto Rico Operations Company (MPROC), located in Juncos, Puerto Rico. The change also requested other related minor documentation updates .