- Device
- Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S028
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2026-03-19
- Decision code
- OK30
- Date received
- 2026-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to incorporate a change to the nylon balloon supplier site for the Stellarex™ 0.035” OTW Drug-coated Angioplasty Balloon and to reduce the test frequency for the Balloon Burst Test of the Stellarex 035 PTA catheter assembly