PMA P170003S004
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S004
- Product code
- PRC
- Decision date
- 2018-12-18
- Classification
- Drug-coated Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Approval for the addition of 0.018 in guidewire compatibility catheter for the 4 to 7 mm diameter balloon sizes, a 3rd radiopaque marker band for balloon lengths greater than 100 mm and a 150 cm length catheter.
Current openFDA PMA Record#
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S004
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2018-12-18
- Decision code
- APPR
- Date received
- 2018-10-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of 0.018 in guidewire compatibility catheter for the 4 to 7 mm diameter balloon sizes, a 3rd radiopaque marker band for balloon lengths greater than 100 mm and a 150 cm length catheter.