LUTONIX DRUG COATED BALLOON PTA CATHETER
FDA premarket approval P130024/S012 · decided 2016-05-05
Approval details
- PMA number
- P130024
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LUTONIX DRUG COATED BALLOON PTA CATHETER
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2016-04-29
- Decision date
- 2016-05-05
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for minor changes to the Indications for Use statement and Instructions for Use document.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.