Attesta™ S DR MRI SureScan™
GUDID 00763000316822
IPG ATDRS1 ATTESTA DR USA
MEDTRONIC, INC.
Dual-chamber implantable pacemaker, rate-responsive| Primary Device ID | 00763000316822 |
| NIH Device Record Key | 58a11fd3-43ca-4e57-ad0a-307eec550a9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Attesta™ S DR MRI SureScan™ |
| Version Model Number | ATDRS1 |
| Company DUNS | 006261481 |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000316822 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P980035
FDA Product Code
| NVZ | Pulse generator, permanent, implantable |
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 | 2020-08-07 |
| Device Publish Date | 2020-07-30 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000300623 - N/A | 2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM |
| 00763000596958 - InterStim™ SureScan™ | 2026-01-08 LEAD 978B133 ISTM SSMRI 4.32MM EMAN GLBL |
| 00763000596996 - InterStim™ SureScan™ | 2026-01-08 LEAD 978B141 ISTM SSMRI 4.32MM EMAN GLBL |
| 00763000994198 - N/A | 2026-01-07 ACCY KIT 3550-68 TWIST LOCK SCRN CBL MDR |
| 00199150065684 - NA | 2026-01-06 CUSTOM PACK BB11W65R6 HLO SPECTRUM |
| 00199150065691 - NA | 2026-01-06 CUSTOM PACK BB6V93R18 EVL A 3/8 E |
| 00199150065745 - NA | 2026-01-06 CUSTOM PACK BB10V37R6 EVL 1/4 PED |
| 20199150065763 - NA | 2026-01-06 CUSTOM PACK BB11V27R2 10PK ACC 3/8 CONN |
Trademark Results [Attesta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ATTESTA 97673527 not registered Live/Pending |
Attesta Inc. 2022-11-11 |
 ATTESTA 97623455 not registered Live/Pending |
Attesta Labs Inc. 2022-10-07 |
 ATTESTA 97623443 not registered Live/Pending |
Attesta Labs Inc. 2022-10-07 |
 ATTESTA 88603362 not registered Live/Pending |
Medtronic, Inc. 2019-09-04 |
 ATTESTA 86885876 not registered Dead/Abandoned |
Medtronic, Inc. 2016-01-25 |
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