PMA P180050S010
- Device
- Barostim™ System Heart Failure
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S010
- Product code
- DSR
- Decision date
- 2023-10-23
- Classification
- Cardiovascular
- Generic name
- Stimulator, carotid sinus nerve
- Approval order statement
- qualification of an alternate supplier for the polyester mesh component for the Carotid Sinus Lead
Current openFDA PMA Record#
- Device
- Barostim™ System Heart Failure
- Applicant
- Cvrx, Inc.
- PMA number
- P180050
- Supplement
- S010
- Product code
- DSR
- Generic name
- Stimulator, carotid sinus nerve
- Decision date
- 2023-10-23
- Decision code
- OK30
- Date received
- 2023-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of an alternate supplier for the polyester mesh component for the Carotid Sinus Lead