PMA P160024S014
- Device
- LifeStream™ Balloon Expandable Vascular Covered Stent
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P160024
- Supplement
- S014
- Product code
- PRL
- Decision date
- 2025-09-29
- Classification
- Cardiovascular
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- an additional manufacturing facility for the stent covering process
Current openFDA PMA Record#
- Device
- LifeStream™ Balloon Expandable Vascular Covered Stent
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P160024
- Supplement
- S014
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2025-09-29
- Decision code
- OK30
- Date received
- 2025-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional manufacturing facility for the stent covering process