LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
FDA premarket approval P130024/S006 · decided 2016-01-29
Approval details
- PMA number
- P130024
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2015-07-13
- Decision date
- 2016-01-29
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CHANGE IN STUDY DESIGN, PRIMARY EFFECTIVENESS COMPARATOR AND PRIMARY SAFETY COMPARATOR.
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