Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
FDA premarket approval P160049/S019 · decided 2022-07-15
Approval details
- PMA number
- P160049
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2022-06-14
- Decision date
- 2022-07-15
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Change in supplier of a packaging material.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.