Tack Endovascular System (4F, 1.5-4.5mm)
FDA premarket approval P190027 · decided 2020-04-10
Approval details
- PMA number
- P190027
- Trade name
- Tack Endovascular System (4F, 1.5-4.5mm)
- Generic name
- Scaffold, dissection repair
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- Date received
- 2019-10-01
- Decision date
- 2020-04-10
- Days to decision
- 192 days
- Decision code
- APWD
- Product code
- QCT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
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