VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS

FDA premarket approval P980023/S046 · decided 2012-02-22

Approval details

PMA number

P980023

Supplement

S046

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS

Generic name

Permanent defibrillator electrodes

Applicant

Biotronik, Inc.

Date received

2011-11-14

Decision date

2012-02-22

Days to decision

100 days

Decision code

APPR

Product code

NVY

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR THE FOLLOWING: 1) ADDITION OF TRADE NAMES VIGILA AND VOLTA FOR THE LINOX AND LINOX SMART DEFIBRILLATION LEADS; 2) CHANGE TO INDICATIONS FOR USE STATEMENT TO CLARIFY THAT THE VIGILA AND VOLTA LEADS MAYBE USED WITH ANY MANUFACTURERS' ICDS; AND 3) ACCESSORY KITS FOR USE WITH THE VIGILA AND VOLTA LEADS.

510(k) clearances by this applicant