PMA P230007S009
- Device
- TriClip G4 System, TriClip G5 Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S009
- Product code
- NPS
- Decision date
- 2025-02-10
- Classification
- Cardiovascular
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Approval order statement
- implementation of a PTFE cover as a manufacturing aid during injection molding
Current openFDA PMA Record#
- Device
- TriClip G4 System, TriClip G5 Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S009
- Product code
- NPS
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Decision date
- 2025-02-10
- Decision code
- OK30
- Date received
- 2025-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a PTFE cover as a manufacturing aid during injection molding