PMA P170003S021
- Device
- Lutonix 018 and 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S021
- Product code
- PRC
- Decision date
- 2021-06-03
- Generic name
- Drug-coated 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 PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S021
- Product code
- PRC
- Generic name
- Drug-coated 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.