PMA P240012

Device: AeroPace® System
Applicant: Lungpacer Medical USA, Inc.
Product code: SDL
Decision date: 2026-02-20
Generic name: Transvenous temporary phrenic nerve stimulator
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240012.

Current openFDA PMA Record#

Device: AeroPace® System
Applicant: Lungpacer Medical USA, Inc.
PMA number: P240012
Supplement: S005
Product code: SDL
Generic name: Transvenous temporary phrenic nerve stimulator
Decision date: 2026-02-20
Decision code: APPR
Date received: 2026-01-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240012.