LUTONIX DRUG COATED BALLOON (DCB)
FDA premarket approval P130024/S001 · decided 2015-01-22
Approval details
- PMA number
- P130024
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUTONIX DRUG COATED BALLOON (DCB)
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2014-11-24
- Decision date
- 2015-01-22
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- APPROVAL FOR A CHANGE IN BALLOON PROTECTOR FROM A SLIDE-OFF TO A PEELAWAY DESIGN.
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