STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
FDA premarket approval P160049/S003 · decided 2018-11-16
Approval details
- PMA number
- P160049
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2018-10-01
- Decision date
- 2018-11-16
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for a labeling update with 2 year data.
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