- Device
- Attain StarFix Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P060039
- Supplement
- S099
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2020-03-06
- Decision code
- OK30
- Date received
- 2020-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer two incoming inspection activities for device components from Medtronic Rice Creek to Medtronic Puerto Rico Operations Company Villalba/Juncos sites.