LUTONIX 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S012 · decided 2019-10-02
Approval details
- PMA number
- P170003
- Supplement
- S012
- 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
- 2019-09-18
- Decision date
- 2019-10-02
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for updates to your device labeling to communicate safety information regarding paclitaxel-coated devices for treatment of femoropopliteal arterial disease.
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