PMA P190009S009

Device: OPRA™ Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S009
Product code: PJY
Decision date: 2025-08-14
Classification: Orthopedic
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
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 P190009

Current openFDA PMA Record#

Device: OPRA™ Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S009
Product code: PJY
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Decision date: 2025-08-14
Decision code: APPR
Date received: 2025-07-24
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 P190009