LUTONIX® 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S007 · decided 2019-10-04
Approval details
- PMA number
- P170003
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- LUTONIX® 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2019-04-10
- Decision date
- 2019-10-04
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for updates to the Instructions for Use for the Lutonix 035 Model 9010 to reflect the 24-month data from the AV IDE Cohort Post-Approval Study.
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