Approved products
| Product Name: | IMPELLA circulatory assist pump catheters |
| Approval Number: | 22800BZI00032000 |
| Approved: | as of September 27, 2016 |
| Latest Product Inserts: | IMPELLA 2.5 (See PMDA Product Insert, Japanese Language) IMPELLA 5.0 (See PMDA Product Insert, Japanese Language) IMPELLA CP (See PMDA Product Insert, Japanese Language) IMPELLA CP SmartAssist (See PMDA Product Insert, Japanese Language) |
| Product Name: | IMPELLA 5.5 circulatory assist pump catheters |
| Approval Number: | 30300BZI00040000 |
| Approved: | as of November 22, 2021 |
| Latest Product Inserts: | IMPELLA 5.5 SmartAssist (See PMDA Product Insert, Japanese Language) |
| Product Name: | IMPELLA controller |
| Approval Number: | 22800BZI00031000 |
| Approved: | as of September 27, 2016 |
| Latest Product Inserts: | IMPELLA Controller (See PMDA Product Insert, Japanese Language) |
Approval conditions
- In collaboration with the related societies, the guidelines for the appropriate use shall be established, and necessary measures must be taken to ensure that the product is used by the heart team with sufficient knowledge and experience on the procedures, at medical institutions capable of providing a systematic approach to assisted circulation therapy.
- Thorough training must be provided to the heart team to ensure adherence to the guidelines on the appropriate use of the product and to assure safety.