LUTONIX DRUG COATED BALLOON (DCB)
FDA premarket approval P130024/S004 · decided 2015-04-23
Approval details
- PMA number
- P130024
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUTONIX DRUG COATED BALLOON (DCB)
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2015-03-02
- Decision date
- 2015-04-23
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- APPROVAL FOR THE ADDITION OF MARKERS ON THE PROXIMAL CATHETER SHAFT OF THE 40¿100 MM LUTONIX DRUG COATED BALLOON.
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