LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010
FDA premarket approval P170003/S014 · decided 2019-11-26
Approval details
- PMA number
- P170003
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2019-10-03
- Decision date
- 2019-11-26
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for the revised protocol and informed consent for the New Enrollment PAS Registry.
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