Lutonix Drug Coated Balloon
FDA premarket approval P170003/S001 · decided 2018-02-26
Approval details
- PMA number
- P170003
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Lutonix Drug Coated Balloon
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2017-09-25
- Decision date
- 2018-02-26
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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