OPRA System

FDA Premarket Approval P190009 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the 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.

• Device: OPRA System
• Generic Name: Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
• Applicant: Integrum AB
• Date Received: 2021-01-15
• Decision Date: 2021-02-12
• PMA: P190009
• Supplement: S002
• Product Code: PJY
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• Expedited Review: No
• Combination Product: No
• Applicant Address: Integrum AB krokslatts Fabriker 50 molndal Se-43-431

Supplemental Filings

Supplement Number	Date	Supplement Type
P190009		Original Filing
S002	2021-01-15	Normal 180 Day Track No User Fee
S001	2021-01-15	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
07340152100160	P190009	000
07340152100337	P190009	000
07340152100344	P190009	000
07340152100351	P190009	000
07340152100368	P190009	000
07340152100375	P190009	000
07340152100382	P190009	000
07340152101204	P190009	000
07340152101211	P190009	000
07340152101242	P190009	000
07340152101259	P190009	000
07340152101266	P190009	000
07340152101273	P190009	000
07340152101228	P190009	000
07340152101532	P190009	000
07340152100313	P190009	000
07340152100306	P190009	000
07340152101372	P190009	000
07340152101389	P190009	000
07340152100177	P190009	000
07340152100184	P190009	000
07340152100191	P190009	000
07340152100207	P190009	000
07340152100214	P190009	000
07340152100221	P190009	000
07340152100245	P190009	000
07340152100252	P190009	000
07340152100269	P190009	000
07340152100276	P190009	000
07340152100283	P190009	000
07340152100290	P190009	000
07340152101549	P190009	000
07340152102157	P190009	000
07340152102164	P190009	000
07340152102188	P190009	000
07340152102195	P190009	000
07340152102140	P190009	000
07340152102133	P190009	000
07340152102126	P190009	000
07340152102201	P190009	000
07340152100238	P190009	000
07340152102119	P190009	000
07340152102065	P190009	000
07340152102171	P190009	000
07340152101785	P190009	003
07340152101778	P190009	003
07340152101761	P190009	003
07340152101754	P190009	003
07340152101792	P190009	003
07340152102379	P190009	003
07340152102027	P190009	003
07340152101662	P190009	003
07340152101723	P190009	003
07340152102225	P190009	003
07340152101976	P190009	003
07340152102034	P190009	003
07340152101747	P190009	003
07340152101730	P190009	003
07340152101716	P190009	003
07340152102386	P190009	003
07340152101501	P190009	003
07340152101488	P190009	003
07340152101464	P190009	003
07340152101457	P190009	003
07340152101440	P190009	003
07340152101495	P190009	003
07340152102218	P190009	003
07340152101679	P190009	003
07340152101686	P190009	003
07340152101693	P190009	003
07340152101709	P190009	003
07340152101952	P190009	003