Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
FDA premarket approval P160049/S002 · decided 2018-03-12
Approval details
- PMA number
- P160049
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2018-01-22
- Decision date
- 2018-03-12
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for process changes related to the coating process.
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