PMA P180034S005
- Device
- Tack Endovascular System (6F)
- Applicant
- Philips Image Guided Therapy Corporation
- PMA number
- P180034
- Supplement
- S005
- Product code
- QCT
- Decision date
- 2021-09-07
- Generic name
- Scaffold, dissection repair
- Approval order statement
- Approval for the labeling updates which incorporate the final 36-month results from the TOBA II Post Approval Study.
Current openFDA PMA Record#
- Device
- Tack Endovascular System (6F)
- Applicant
- Philips Image Guided Therapy Corporation
- PMA number
- P180034
- Supplement
- S005
- Product code
- QCT
- Generic name
- Scaffold, dissection repair
- Decision date
- 2021-09-07
- Decision code
- APPR
- Date received
- 2021-06-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the labeling updates which incorporate the final 36-month results from the TOBA II Post Approval Study.