PMA P170003S015
- Device
- LUTONIX® 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S015
- Product code
- PRC
- Decision date
- 2019-12-18
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Implement a minor change affecting the hub component of drug coated balloon catheter.
Current openFDA PMA Record#
- Device
- LUTONIX® 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S015
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2019-12-18
- Decision code
- OK30
- Date received
- 2019-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a minor change affecting the hub component of drug coated balloon catheter.