Stellarex 0.035OTW Drug-coated Angioplasty Balloon
FDA premarket approval P160049/S015 · decided 2022-03-25
Approval details
- PMA number
- P160049
- Supplement
- S015
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Stellarex 0.035OTW Drug-coated Angioplasty Balloon
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2021-09-29
- Decision date
- 2022-03-25
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon. The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 180 mm in length in superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
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