PMA P190009S010

Device: OPRA Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S010
Product code: PJY
Decision date: 2026-03-12
Classification: Orthopedic
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Approval order statement: approval for revisions to the device labeling that was updated to include information on the Post-Approval Study (PAS), TFAOS PAS, for the OPRA Implant System

Current openFDA PMA Record#

Device: OPRA Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S010
Product code: PJY
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Decision date: 2026-03-12
Decision code: APPR
Date received: 2025-09-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for revisions to the device labeling that was updated to include information on the Post-Approval Study (PAS), TFAOS PAS, for the OPRA Implant System