LUTONIX® 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S002 · decided 2018-06-15
Approval details
- PMA number
- P170003
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LUTONIX® 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2018-05-18
- Decision date
- 2018-06-15
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for minor updates to the Instructions for Use.
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