PMA P130024S014
- Device
- LUTONIX 035 DRUG COATED BALLOON PTA CATETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S014
- Product code
- ONU
- Decision date
- 2016-11-14
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for a shelf life extension from 24 to 36 months.
Current openFDA PMA Record#
- Device
- LUTONIX 035 DRUG COATED BALLOON PTA CATETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S014
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2016-11-14
- Decision code
- APPR
- Date received
- 2016-07-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a shelf life extension from 24 to 36 months.