- Device
- Stellarex 0.035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S017
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2022-04-11
- Decision code
- OK30
- Date received
- 2022-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introducing an additional sterilization chamber for devices produced in Plymouth MN.