FDA PMA

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

PMA 번호: P070008 · 2026-09-25

신청자Biotronik, Inc.

결정일2026-09-25

PMA 번호P070008

제품 코드NKE

의료기기 등급등급 3

의학적 전문분야U

자문 위원회CV

기기 요약

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) 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 NKE. It was reviewed by the CV advisory panel.

자주 묻는 질문

What is the Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)?

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Biotronik, Inc..

When did Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) receive FDA 510(k) clearance?

The clearance date for Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) can be found in the official FDA records.

Who is the listed applicant for Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)?

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 Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)?

The FDA product code for Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) is NKE.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

기기 요약

자주 묻는 질문

관련 임상시험

공식 출처