Ranger Paclitaxel-Coated PTA Balloon Catheter
FDA premarket approval P190019 · decided 2020-10-30
Approval details
- PMA number
- P190019
- Trade name
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-07-22
- Decision date
- 2020-10-30
- Days to decision
- 466 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the Ranger Paclitaxel-Coated PTA Balloon Catheter. This device is indicated for percutaneous transluminal angioplasty (PTA) of de novo or restenotic lesions up to 180 mm in length located in native superficial femoral and proximal popliteal arteries (SFA/PPA) with reference vessel diameters of 4 -7 mm.
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