PMA P130024S001
- Device
- LUTONIX DRUG COATED BALLOON (DCB)
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S001
- Product code
- ONU
- Decision date
- 2015-01-22
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- APPROVAL FOR A CHANGE IN BALLOON PROTECTOR FROM A SLIDE-OFF TO A PEELAWAY DESIGN.
Current openFDA PMA Record#
- Device
- LUTONIX DRUG COATED BALLOON (DCB)
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S001
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2015-01-22
- Decision code
- APPR
- Date received
- 2014-11-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN BALLOON PROTECTOR FROM A SLIDE-OFF TO A PEELAWAY DESIGN.