PMA P080006S175
- Device
- Attain Stability Quad MRI Surescan
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S175
- Product code
- OJX
- Decision date
- 2023-03-17
- Classification
- Cardiovascular
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- Transfer of component extrusion lines from the Santa Rosa facility to the Medtronic Danvers facility.
Current openFDA PMA Record#
- Device
- Attain Stability Quad MRI Surescan
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S175
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2023-03-17
- Decision code
- OK30
- Date received
- 2023-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of component extrusion lines from the Santa Rosa facility to the Medtronic Danvers facility.