PMA P110028S017
- Device
- Absolute Pro Vascular Self-Expanding Stent System.
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P110028
- Supplement
- S017
- Product code
- NIO
- Decision date
- 2017-04-14
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Addition of new equipment for stent laser cutting operations and modifications to associated manufacturing processes.
Current openFDA PMA Record#
- Device
- Absolute Pro Vascular Self-Expanding Stent System.
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P110028
- Supplement
- S017
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2017-04-14
- Decision code
- OK30
- Date received
- 2017-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of new equipment for stent laser cutting operations and modifications to associated manufacturing processes.