implantable pacemaker Pulse-generator
PMA 번호: P950037 · 2026-09-25
광고
결정일2026-09-25
PMA 번호P950037
제품 코드DXY
의료기기 등급등급 3
의학적 전문분야C
규정 번호21 CFR 8
자문 위원회CV
기기 요약
implantable pacemaker Pulse-generator is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements.
자주 묻는 질문
What is the implantable pacemaker Pulse-generator?
implantable pacemaker Pulse-generator is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Biotronik, Inc..
When did implantable pacemaker Pulse-generator receive FDA 510(k) clearance?
The clearance date for implantable pacemaker Pulse-generator can be found in the official FDA records.
Who is the listed applicant for implantable pacemaker Pulse-generator?
The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for implantable pacemaker Pulse-generator?
The FDA product code for implantable pacemaker Pulse-generator is DXY. This falls under the Clinical Chemistry category.
관련 임상시험
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751의료 기기 인공지능 보조 유로-캠 캐터터 평가 시스템:膀胱癌 진단을 위한NOT_YET_RECRUITING
공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.
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