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PMA P970004S310

Device
InterStim Therapy System, Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S310
Product code
EZW
Decision date
2020-05-08
Generic name
Stimulator, electrical, implantable, for incontinence
Approval order statement
Change requested to modify the procedure for the assessment of device bioburden at Medtronic's final device manufacturing facilities-Medtronic Puerto Rico Operations Company, located in Juncos, Puerto Rico .The change also requested other related administrative changes which update the procedure.

Current openFDA PMA Record#

Device
InterStim Therapy System, Verify Evaluation System (SNS Urinary)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S310
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2020-05-08
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 modify the procedure for the assessment of device bioburden at Medtronic's final device manufacturing facilities-Medtronic Puerto Rico Operations Company, located in Juncos, Puerto Rico .The change also requested other related administrative changes which update the procedure.