PMA P190027S005
- Device
- Tack Endovascular System (4F, 1.5-4.5mm)
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- PMA number
- P190027
- Supplement
- S005
- Product code
- QCT
- Decision date
- 2022-11-09
- Generic name
- Scaffold, dissection repair
- Approval order statement
- Approval for the post-approval labeling update to include the 36-month outcomes of the TOBA II BTK Post-Approval Study.
Current openFDA PMA Record#
- Device
- Tack Endovascular System (4F, 1.5-4.5mm)
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- PMA number
- P190027
- Supplement
- S005
- Product code
- QCT
- Generic name
- Scaffold, dissection repair
- Decision date
- 2022-11-09
- Decision code
- APPR
- Date received
- 2022-08-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the post-approval labeling update to include the 36-month outcomes of the TOBA II BTK Post-Approval Study.