PMA P130024S023
- Device
- Lutonix Drug Coated Ballon
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S023
- Product code
- ONU
- Decision date
- 2018-06-28
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Change in the frequency of endotoxin monitoring.
Current openFDA PMA Record#
- Device
- Lutonix Drug Coated Ballon
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S023
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2018-06-28
- Decision code
- OK30
- Date received
- 2018-06-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the frequency of endotoxin monitoring.