| Z-1996-2021 | Class II | Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prom | May 26, 2021 |
| Z-1122-2020 | Class II | Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 0081033 | December 24, 2019 |
| Z-1124-2020 | Class II | Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN- | December 24, 2019 |
| Z-1123-2020 | Class II | US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GT | December 24, 2019 |
| Z-1120-2020 | Class II | Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN- | December 24, 2019 |
| Z-1125-2020 | Class II | Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. G | December 24, 2019 |
| Z-1121-2020 | Class II | Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 0081033 | December 24, 2019 |
| Z-1714-2019 | Class II | Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. | March 21, 2019 |
| Z-1712-2019 | Class II | Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prom | March 21, 2019 |
| Z-1715-2019 | Class II | Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. | March 21, 2019 |
| Z-1713-2019 | Class II | Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and P | March 21, 2019 |
| Z-1716-2019 | Class II | Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion. | March 21, 2019 |
| Z-2740-2017 | Class II | PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Nu | May 22, 2017 |