PMA P030045S005
- Device
- Visi-Pro Balloon-Expandable Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S005
- Product code
- NIO
- Decision date
- 2019-05-23
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Implement new heat sealing equipment.
Current openFDA PMA Record#
- Device
- Visi-Pro Balloon-Expandable Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P030045
- Supplement
- S005
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2019-05-23
- Decision code
- OK30
- Date received
- 2019-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement new heat sealing equipment.