Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
FDA premarket approval P160049/S013 · decided 2021-11-18
Approval details
- PMA number
- P160049
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- 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
- 2021-09-17
- Decision date
- 2021-11-18
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for updated labeling to include your 5-year PAS results.
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