PMA P080007S021
- Device
- Bard E-LUMINEXX and LIFESTAR Vascular Stents
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P080007
- Supplement
- S021
- Product code
- NIO
- Decision date
- 2018-01-16
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Addition of alternate laser cutting equipment.
Current openFDA PMA Record#
- Device
- Bard E-LUMINEXX and LIFESTAR Vascular Stents
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P080007
- Supplement
- S021
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2018-01-16
- Decision code
- OK30
- Date received
- 2017-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternate laser cutting equipment.