PMA P230007S011
- Device
- TriClip Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S011
- Product code
- NPS
- Decision date
- 2025-04-18
- Classification
- Cardiovascular
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Approval order statement
- a change to the manufacturing process for a material component of the delivery system
Current openFDA PMA Record#
- Device
- TriClip Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S011
- Product code
- NPS
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Decision date
- 2025-04-18
- Decision code
- OK30
- Date received
- 2025-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the manufacturing process for a material component of the delivery system