Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
FDA premarket approval P160049/S004 · decided 2019-10-11
Approval details
- PMA number
- P160049
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2019-01-23
- Decision date
- 2019-10-11
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for 150 mm and 200 mm balloon lengths for the Stellarex 0.035 OTW Drug-coated Angioplasty Balloon.
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