Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon
FDA premarket approval P160049/S027 · decided 2025-11-24
Approval details
- PMA number
- P160049
- Supplement
- S027
- 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
- 2025-08-29
- Decision date
- 2025-11-24
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- for the implementation of an alternative paclitaxel active pharmaceutical ingredient utilized in the drug coating of the Stellarex 0.035" OTW Drug-coated Angioplasty Balloon
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.