LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
FDA premarket approval P130024/S008 · decided 2015-11-24
Approval details
- PMA number
- P130024
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2015-11-09
- Decision date
- 2015-11-24
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILS REGARDING THE USE OF BARE METAL STENTS WITH THE DEVICE FOR BAILOUT STENTING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.