PMA P130024S029
- Device
- Lutonix Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S029
- Product code
- ONU
- Decision date
- 2019-09-13
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for updates to the device labeling.
Current openFDA PMA Record#
- Device
- Lutonix Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S029
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2019-09-13
- Decision code
- APPR
- Date received
- 2019-09-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the device labeling.