Stellarex 0.035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
FDA premarket approval P160049/S017 · decided 2022-04-11
Approval details
- PMA number
- P160049
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Stellarex 0.035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2022-03-17
- Decision date
- 2022-04-11
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Introducing an additional sterilization chamber for devices produced in Plymouth MN.
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