| Z-1471-2026 | Class I | Impella RP. Product Code: 0046-0011. | January 27, 2026 |
| Z-1470-2026 | Class I | Impella RP Flex with SmartAssist. Product Code: 1000323. | January 27, 2026 |
| Z-1469-2026 | Class I | Impella RP with SmartAssist. Product Code: 0046-0035. | January 27, 2026 |
| Z-1030-2026 | Class II | Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. | December 4, 2025 |
| Z-0069-2026 | Class I | Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following | October 1, 2025 |
| Z-0136-2026 | Class I | Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AI | September 16, 2025 |
| Z-2568-2025 | Class I | Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist p | August 20, 2025 |
| Z-2164-2025 | Class I | Automated Impella Controller (AIC), used in left heart support blood pump, including the following: | June 23, 2025 |
| Z-0830-2025 | Class I | Impella RP Flex with SmartAssist; Product Number: 1000323; | December 12, 2024 |
| Z-0829-2025 | Class I | Impella RP with SmartAssist; Product Number: 0046-0035; | December 12, 2024 |
| Z-2969-2024 | Class II | Impella CP Smart Assist Set; Product Code: 1000402; | August 5, 2024 |
| Z-2968-2024 | Class II | Impella 5.5 Set AU; Product Code: 1000361; | August 5, 2024 |
| Z-2966-2024 | Class II | Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; | August 5, 2024 |
| Z-2971-2024 | Class II | Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; | August 5, 2024 |
| Z-2956-2024 | Class II | Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; | August 5, 2024 |
| Z-2970-2024 | Class II | Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; | August 5, 2024 |
| Z-2958-2024 | Class II | Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; | August 5, 2024 |
| Z-2954-2024 | Class II | Impella CP Smart Assist Set, EU; Product Code: 0048-0014; | August 5, 2024 |
| Z-2961-2024 | Class II | Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; | August 5, 2024 |
| Z-2960-2024 | Class II | Impella CP Smart Assist Set APAC; Product Code: 0048-0047; | August 5, 2024 |