PMA P130024S015
- Device
- LUTONIX DRUG COATED BALLOON PTA CATETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S015
- Product code
- ONU
- Decision date
- 2016-10-14
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval of changes to the post-approval study for the device.
Current openFDA PMA Record#
- Device
- LUTONIX DRUG COATED BALLOON PTA CATETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S015
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2016-10-14
- Decision code
- APPR
- Date received
- 2016-08-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of changes to the post-approval study for the device.