Lutonix 018 and 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S021 · decided 2021-06-03
Approval details
- PMA number
- P170003
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lutonix 018 and 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2021-03-08
- Decision date
- 2021-06-03
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for revised release specifications for related substances.
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