PMA P130024S009
- Device
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S009
- Product code
- ONU
- Decision date
- 2017-02-07
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for Lutonix DCB is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130024S009B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S009
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2017-02-07
- Decision code
- APPR
- Date received
- 2016-01-04
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for Lutonix DCB is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.