DEVICE: INTERSTIM® II (00643169974760)
Device Identifier (DI) Information
INTERSTIM® II
3058
Not in Commercial Distribution
MEDTRONIC, INC.
3058
Not in Commercial Distribution
MEDTRONIC, INC.
INS 3058 INTERSTIM II EMAN US GRC
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61391 | Implantable incontinence-control electrical stimulation system pulse generator |
A sterile, hermetically-sealed, battery-powered component of an implantable incontinence-control pelvic electrical stimulation system, intended to be implanted beneath the skin (e.g., upper buttock area) to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via implantable electrodes (not included), and the pulse generator may be controlled by an external programmer.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EZW | Stimulator, electrical, implantable, for incontinence |
QON | Implanted electrical device intended for treatment of fecal incontinence |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P080025 | 154 |
P970004 | 259 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -18 and 52 Degrees Celsius |
Storage Environment Temperature: between 0 and 125 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
837a5598-7ceb-406d-9721-9a8ef5ae2b1a
December 23, 2022
2
May 24, 2019
December 23, 2022
2
May 24, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com