PMA P230040S024
- Device
- CorPASS System
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S024
- Product code
- MOM
- Decision date
- 2025-11-25
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- the addition of an alternative supplier for the implant sensor printed circuit board
Current openFDA PMA Record#
- Device
- CorPASS System
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S024
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2025-11-25
- Decision code
- OK30
- Date received
- 2025-10-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of an alternative supplier for the implant sensor printed circuit board