Product code LKK
- Device name
- Pump, Infusion, Implanted, Programmable
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- HO
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P890055S093 | MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM | Intera Oncology | 2026-03-16 |
| P890055S092 | lntera 3000 Hepatic Artery Infusion Pump | Intera Oncology | 2026-02-26 |
| P860004S456 | Drug Delivery Infusion Pump Model 8667 | Medtronic, Inc. | 2026-02-12 |
| P860004S457 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (Drug Delivery Infusion Pump 8667) | Medtronic, Inc. | 2026-02-06 |
| P860004S443 | SynchroMed ™ Infusion System, Ascenda ® Intrathecal Catheters | Medtronic, Inc. | 2026-01-20 |
| P860004S455 | SynchroMed Infusion System; Ascenda Intrathecal Catheters | Medtronic, Inc. | 2025-12-22 |
| P860004S453 | SynchroMed™ Infusion Systems | Medtronic, Inc. | 2025-12-19 |
| P860004S454 | SynchroMed Infusion System, Ascenda Intrathecal Catheters | Medtronic, Inc. | 2025-11-26 |
| P860004S451 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters | Medtronic, Inc. | 2025-11-13 |
| P860004S452 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters | Medtronic, Inc. | 2025-10-16 |
| P860004S450 | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (Drug Delivery Infusion Pump 8667); (Drug Delivery Infusion | Medtronic, Inc. | 2025-09-18 |
| P860004S449 | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters | Medtronic, Inc. | 2025-09-05 |
| P860004S448 | SynchroMed Infusion System, Ascenda Intrathecal Catheters | Medtronic, Inc. | 2025-08-29 |
| P860004S447 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters | Medtronic, Inc. | 2025-08-28 |
| P860004S446 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters | Medtronic, Inc. | 2025-07-17 |
| P860004S445 | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters | Medtronic, Inc. | 2025-07-17 |
| P860004S444 | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters | Medtronic, Inc. | 2025-06-18 |
| P080012S075 | PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM | Infusyn Therapeutics, LLC | 2025-06-18 |
| P860004S442 | SynchroMed® Infusion System, Ascenda ® Intrathecal Catheters | Medtronic, Inc. | 2025-05-21 |
| P890055S089 | Intera 3000 Hepatic Artery Infusion Pump | Intera Oncology | 2025-05-09 |
| P890055S090 | Intera 3000 Hepatic Arterial Infusion Pump | Intera Oncology | 2025-05-07 |
| P860004S441 | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters | Medtronic, Inc. | 2025-03-14 |
| P860004S440 | SynchroMed Infusion System; Ascenda Intrathecal Catheters | Medtronic, Inc. | 2025-03-14 |
| P860004S439 | MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM | Medtronic, Inc. | 2025-02-13 |
| P860004S432 | SynchroMed Infusion System, Ascenda Intrathecal Catheters | Medtronic, Inc. | 2025-02-12 |
| P860004S438 | SynchroMed® Infusion System | Medtronic, Inc. | 2025-01-15 |
| P860004S433 | SynchroMed Infusion System, Ascenda Intrathecal Catheters | Medtronic, Inc. | 2025-01-06 |
| P860004S436 | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters | Medtronic, Inc. | 2024-12-18 |
| P860004S435 | Drug Delivery Infusion Pump/SynchroMed | Medtronic, Inc. | 2024-12-12 |
| P080012S074 | Prometra Programmable Infusion Pump System | Infusyn Therapeutics, LLC | 2024-12-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199150021277 | NA | MEDTRONIC, INC. | 2026-05-02 |
| 00763000004101 | NA | MEDTRONIC, INC. | 2025-08-25 |
| 00763000875862 | N'VISION™ | MEDTRONIC, INC. | 2023-11-16 |
| 00763000875718 | NA | MEDTRONIC, INC. | 2023-11-16 |
| 00763000420994 | N/A | MEDTRONIC, INC. | 2020-12-21 |
| 00763000315443 | N'Vision | MEDTRONIC, INC. | 2020-08-13 |
| 00810335020266 | Prometra Clinician Programmer Print Tool | Flowonix Medical, Inc. | 2020-06-05 |
| 00643169183704 | NA | MEDTRONIC, INC. | 2018-11-22 |
| 00763000017606 | N/A | MEDTRONIC, INC. | 2018-11-02 |
| 00643169866218 | N'VISION™ | MEDTRONIC, INC. | 2017-10-02 |
| 00643169778054 | N/A | MEDTRONIC, INC. | 2017-09-01 |
| 00643169572072 | N'VISION® | MEDTRONIC, INC. | 2017-04-07 |
| 10681490185209 | NA | MEDTRONIC, INC. | 2016-04-27 |
| 10681490185216 | NA | MEDTRONIC, INC. | 2016-04-27 |
| 00613994747044 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 10681490183984 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00643169342873 | N'VISION ® | MEDTRONIC, INC. | 2014-09-23 |
| 00613994348661 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00643169108196 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00613994997845 | N'VISION™ | MEDTRONIC, INC. | 2014-09-23 |
| 00613994997838 | N'VISION™ | MEDTRONIC, INC. | 2014-09-23 |
| 00613994452191 | N'VISION® | MEDTRONIC, INC. | 2014-09-23 |
| 10886704072881 | CODMAN | Cerenovus, Inc. | 2014-09-20 |
| 10886704071457 | MEDSTREAM | Codman Neuro Sciences Sàrl | 2014-09-20 |
| 10886704064954 | MEDSTREAM | Medos International Sàrl | 2014-09-20 |
| 10886704043829 | CODMAN | Cerenovus, Inc. | 2014-09-20 |
| 10886704043744 | NA | Medos International Sàrl | 2014-09-20 |
| 10886704043737 | NA | Medos International Sàrl | 2014-09-20 |
| 10886704043720 | NA | Medos International Sàrl | 2014-09-20 |
| 10886704043713 | NA | Medos International Sàrl | 2014-09-20 |