PMA P080007S027
- Device
- Bard E- Luminexx Vascular Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P080007
- Supplement
- S027
- Product code
- NIO
- Decision date
- 2022-05-26
- Generic name
- STENT, ILIAC
- Approval order statement
- an alternative supplier for injection molded components on the delivery system
Current openFDA PMA Record#
- Device
- Bard E- Luminexx Vascular Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P080007
- Supplement
- S027
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2022-05-26
- Decision code
- OK30
- Date received
- 2022-05-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative supplier for injection molded components on the delivery system