BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

FDA premarket approval P000009/S051 · decided 2013-03-18

Approval details

PMA number

P000009

Supplement

S051

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

Biotronik, Inc.

Date received

2012-12-18

Decision date

2013-03-18

Days to decision

90 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR THE ILESTO 7/5 VR-T ICD, ILESTO 7/5 VR-T DX ICD, ILESTO 7/5 DR-T ICD, ILESTO 7/5 HFT CRT-D; IFORIA 7/5 VR-T ICD, IFORIA 7/5 VR-T DX ICD, IFORIA 7/5 DR-T ICD, IFORIA 7/5 HF-T CRT-D; AND THE PSW 1205.U.

510(k) clearances by this applicant