PMA P080006S173

Device: Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S173
Product code: OJX
Decision date: 2022-11-22
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.

Current openFDA PMA Record#

Device: Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S173
Product code: OJX
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.