PMA P130024S040
- Device
- Lutonix 018 and 035 Drug Coated Balloon
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S040
- Product code
- ONU
- Decision date
- 2021-06-03
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for revised release specifications for related substances.
Current openFDA PMA Record#
- Device
- Lutonix 018 and 035 Drug Coated Balloon
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S040
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2021-06-03
- Decision code
- APPR
- Date received
- 2021-03-08
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for revised release specifications for related substances.