IFORIA VR-T ICD, LLESTO VR-T ICD, LUMAX VR-T ICD,IFORIA VR-T DX ICD, LLESTO VR-T DX ICD, LUMAX VR-T DX ICD,

FDA premarket approval P050023/S068 · decided 2013-08-14

Approval details

PMA number

P050023

Supplement

S068

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

IFORIA VR-T ICD, LLESTO VR-T ICD, LUMAX VR-T ICD,IFORIA VR-T DX ICD, LLESTO VR-T DX ICD, LUMAX VR-T DX ICD,

Generic name

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant

Biotronik, Inc.

Date received

2013-07-16

Decision date

2013-08-14

Days to decision

29 days

Decision code

OK30

Product code

MRM

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

IMPLEMENT A NEW ETHYLENE OXIDE STERILIZATION CYCLE AT A CONTRACT STERILIZATION SITE.

510(k) clearances by this applicant