PMA P080007S003
- Device
- E-LUMINEXX VASCULAR STENT
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P080007
- Supplement
- S003
- Product code
- NIO
- Decision date
- 2010-09-15
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE PROCEDURES FOR IMPLEMENTING SHELF LIVES OF RAW MATERIALS.
Current openFDA PMA Record#
- Device
- E-LUMINEXX VASCULAR STENT
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P080007
- Supplement
- S003
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2010-09-15
- Decision code
- APPR
- Date received
- 2010-03-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE PROCEDURES FOR IMPLEMENTING SHELF LIVES OF RAW MATERIALS.