STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
FDA premarket approval P160049 · decided 2017-07-26
Approval details
- PMA number
- P160049
- Trade name
- STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2016-11-02
- Decision date
- 2017-07-26
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval of the Stellarex 0.035 OTW Drug-coated Angioplasty Balloon. This device is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
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