Intellis™ AdaptiveStim™

GUDID 00763000849047

INS 97715 INTELLIS US EMAN CARDIO

MEDTRONIC, INC.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

• Primary Device ID: 00763000849047
• NIH Device Record Key: d97f7a0e-a5db-4490-ba06-1d34fff3d9cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intellis™ AdaptiveStim™
• Version Model Number: 97715
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000849047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• LGW: Stimulator, spinal-cord, totally implanted for pain relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-14
• Device Publish Date: 2024-05-06

Devices Manufactured by MEDTRONIC, INC.

• 00199150031610 - NA: 2025-07-21 CUSTOM PACK BB1U06R24 CHRIS AD
• 00199150032464 - NA: 2025-07-21 CUSTOM PACK BB10R35R4 CP PRIME
• 20199150032482 - NA: 2025-07-21 CUSTOM PACK 6S19R4 10PK DIALYSIS
• 00199150033423 - NA: 2025-07-21 CUSTOM PACK BB12B90R7 SPECTRU
• 20199150033571 - NA: 2025-07-21 CUSTOM PACK BB2U59R3 2PK 1/4 TBL L
• 00199150033614 - NA: 2025-07-21 CUSTOM PACK BB10J74R14 3/8CNTRIS
• 00199150034246 - NA: 2025-07-21 CUSTOM PACK BB11J86R12 ADULT E
• 00763000925093 - FlexCath Cross™ Transseptal Solution: 2025-07-21 NDL 900302 FLEXCATH CROSS SL 63CM EIFU