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PMA P080025S210

Device
InterStim Therapy System, Verify Evaluation System
Applicant
Medtronic Neuromodulation
Product code
QON
Decision date
2020-11-03
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Approval order statement
Approval to add the use of tin-lead plating for the terminations of both ends of the T8 tantalum capacitors and for the Model 97810 InterStim Micro INS only, change the solder paste stencil tooling for the 1411 capacitor size to increase the amount of solder paste to match the mount used on other capacitor case sizes.

Current openFDA PMA Record#

Device
InterStim Therapy System, Verify Evaluation System
Applicant
Medtronic Neuromodulation
PMA number
P080025
Supplement
S210
Product code
QON
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Decision date
2020-11-03
Decision code
APPR
Date received
2020-08-21
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to add the use of tin-lead plating for the terminations of both ends of the T8 tantalum capacitors and for the Model 97810 InterStim Micro INS only, change the solder paste stencil tooling for the 1411 capacitor size to increase the amount of solder paste to match the mount used on other capacitor case sizes.