Lutonix 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P130024/S021 · decided 2018-02-06
Approval details
- PMA number
- P130024
- Supplement
- S021
- 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
- 2017-12-08
- Decision date
- 2018-02-06
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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