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.
| 00199150064052 - NA | 2025-12-23 CUSTOM PACK BB1B62R41 HLN CHR LNNT |
| 00199150064847 - NA | 2025-12-22 CUSTOM PACK BB12P57R3 HLO IOM FUS M |
| 00199150064861 - NA | 2025-12-22 CUSTOM PACK BB12S99R1 EVL NEONAT |
| 00199150065042 - NA | 2025-12-22 CUSTOM PACK BB8S37R40 HLO PUMP TBL |
| 20199150065244 - NA | 2025-12-22 CUSTOM PACK 11L77R2 20PK ACC PIGTAI |
| 20199150065268 - NA | 2025-12-22 CUSTOM PACK BB12G80R3 10PK ACC VAC |
| 00199150065271 - NA | 2025-12-22 CUSTOM PACK BB7J98R19 EVL 3/8 CIRCU |
| 20199150065343 - NA | 2025-12-22 CUSTOM PACK 8C82R4 5PK ACC AUTOTRANSFU |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.