PMA P230007S022
- Device
- TriClip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S022
- Product code
- NPS
- Decision date
- 2026-05-28
- Classification
- Cardiovascular
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Approval order statement
- an alternate raw material used to manufacture the coating on the delivery catheter (DC) shaft of the MitraClip and TriClip Delivery Systems
Current openFDA PMA Record#
- Device
- TriClip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S022
- Product code
- NPS
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Decision date
- 2026-05-28
- Decision code
- OK30
- Date received
- 2026-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate raw material used to manufacture the coating on the delivery catheter (DC) shaft of the MitraClip and TriClip Delivery Systems