PMA P080006S193

Device: Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598), Attain Stability
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S193
Product code: OJX
Decision date: 2026-06-24
Classification: Cardiovascular
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement: reduced stability testing intervals for various cardiac lead families containing Dexamethasone or Beclomethasone Dipropionate

Current openFDA PMA Record#

Device: Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598), Attain Stability
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S193
Product code: OJX
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
Decision date: 2026-06-24
Decision code: OK30
Date received: 2026-05-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: reduced stability testing intervals for various cardiac lead families containing Dexamethasone or Beclomethasone Dipropionate