LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
FDA premarket approval P130024/S002 · decided 2015-06-30
Approval details
- PMA number
- P130024
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2015-01-12
- Decision date
- 2015-06-30
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- APPROVAL FOR THE 120 MM AND 150 MM DEVICE SIZES.
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