PMA P170003S014
- Device
- LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S014
- Product code
- PRC
- Decision date
- 2019-11-26
- Classification
- Drug-coated Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Approval for the revised protocol and informed consent for the New Enrollment PAS Registry.
Current openFDA PMA Record#
- Device
- LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S014
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2019-11-26
- Decision code
- APPR
- Date received
- 2019-10-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the revised protocol and informed consent for the New Enrollment PAS Registry.