PMA P030054

Device: Optisure Leads (LDA210, LDA210Q, LDA220Q, LDP210Q, LDP220Q, LDA230Q, LDP230Q); Quartet Leads (1456Q, 1457Q, 1458Q, 1456Q
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S402
Product code: NIK
Decision date: 2026-04-24
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: tooling changes and added in-process inspections for lead manufacturing

Current openFDA PMA Record#

Device: Optisure Leads (LDA210, LDA210Q, LDA220Q, LDP210Q, LDP220Q, LDA230Q, LDP230Q); Quartet Leads (1456Q, 1457Q, 1458Q, 1456Q
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S444
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-04-24
Decision code: OK30
Date received: 2026-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: tooling changes and added in-process inspections for lead manufacturing