PMA P130024S006
- Device
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S006
- Product code
- ONU
- Decision date
- 2016-01-29
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CHANGE IN STUDY DESIGN, PRIMARY EFFECTIVENESS COMPARATOR AND PRIMARY SAFETY COMPARATOR.
Current openFDA PMA Record#
- Device
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S006
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2016-01-29
- Decision code
- APPR
- Date received
- 2015-07-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CHANGE IN STUDY DESIGN, PRIMARY EFFECTIVENESS COMPARATOR AND PRIMARY SAFETY COMPARATOR.