PMA P110028S022
- Device
- ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P110028
- Supplement
- S022
- Product code
- NIO
- Decision date
- 2021-10-12
- Generic name
- STENT, ILIAC
- Approval order statement
- Manufacturing site change for a hypotube supplier.
Current openFDA PMA Record#
- Device
- ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P110028
- Supplement
- S022
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2021-10-12
- Decision code
- OK30
- Date received
- 2021-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing site change for a hypotube supplier.