DEVICE: Proclaim™ (05415067023254)
Device Identifier (DI) Information
Proclaim™
3667
In Commercial Distribution
3667
ST. JUDE MEDICAL, INC.
3667
In Commercial Distribution
3667
ST. JUDE MEDICAL, INC.
Implantable Pulse Generator
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? |
---|---|---|---|---|
64970 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable |
An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P010032 | 096 |
P010032 | 125 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store components and their packaging where they will not come in contact with liquids of any kind. |
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ef52a543-c1a8-4782-b51c-f17bec84c3ad
January 09, 2023
4
November 09, 2015
January 09, 2023
4
November 09, 2015
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(855)478-5833
customerservice@sjm.com
customerservice@sjm.com