PMA P170003S001
- Device
- Lutonix Drug Coated Balloon
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S001
- Product code
- PRC
- Decision date
- 2018-02-26
- Classification
- Drug-coated Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Lutonix Drug Coated Balloon
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S001
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2018-02-26
- Decision code
- APPR
- Date received
- 2017-09-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.