PMA P160024S007
- Device
- LifeStream Balloon Expandable Vascular Covered Stent
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P160024
- Supplement
- S007
- Product code
- PRL
- Decision date
- 2019-09-09
- Classification
- Iliac Covered Stent, Arterial
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- Approval for updates to the LifeStream Balloon Expandable Vascular Covered Stent labeling to incorporate the 3-year results of the BOLSTER Clinical Study.
Current openFDA PMA Record#
- Device
- LifeStream Balloon Expandable Vascular Covered Stent
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P160024
- Supplement
- S007
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2019-09-09
- Decision code
- APPR
- Date received
- 2019-06-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updates to the LifeStream Balloon Expandable Vascular Covered Stent labeling to incorporate the 3-year results of the BOLSTER Clinical Study.