PMA P170003S002
- Device
- LUTONIX® 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S002
- Product code
- PRC
- Decision date
- 2018-06-15
- Classification
- Drug-coated Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Approval for minor updates to the Instructions for Use.
Current openFDA PMA Record#
- Device
- LUTONIX® 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S002
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2018-06-15
- Decision code
- APPR
- Date received
- 2018-05-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for minor updates to the Instructions for Use.