PMA P170003S027
- Device
- Lutonix Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S027
- Product code
- PRC
- Decision date
- 2023-09-07
- Classification
- Cardiovascular
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Addition of oxygen sachets to the packaging of the Lutonix Drug Coated PTA Balloon Catheter.
Current openFDA PMA Record#
- Device
- Lutonix Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S027
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2023-09-07
- Decision code
- OK30
- Date received
- 2023-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of oxygen sachets to the packaging of the Lutonix Drug Coated PTA Balloon Catheter.