PMA P160049S013
- Device
- Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S013
- Product code
- ONU
- Decision date
- 2021-11-18
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for updated labeling to include your 5-year PAS results.
Current openFDA PMA Record#
- Device
- Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S013
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2021-11-18
- Decision code
- APPR
- Date received
- 2021-09-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to include your 5-year PAS results.