LUTONIX® 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S015 · decided 2019-12-18
Approval details
- PMA number
- P170003
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LUTONIX® 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2019-11-25
- Decision date
- 2019-12-18
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Implement a minor change affecting the hub component of drug coated balloon catheter.
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