REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS

FDA premarket approval P950037/S084 · decided 2012-05-08

Approval details

PMA number

P950037

Supplement

S084

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS

Generic name

Pulse Generator, External Pacemaker, Dual Chamber

Applicant

Biotronik, Inc.

Date received

2010-07-14

Decision date

2012-05-08

Days to decision

664 days

Decision code

APPR

Product code

OVJ

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR TWO NEW FAMILIES OF TEMPORARY EXTERNAL PACEMAKER PULSE GENERATORS. NEW FEATURES INCLUDE: 1) REDEL PACING WIRE CONNECTION ADAPTERS; 2) TRIGGER MODES VT AND SST; 3) SENSITIVITY SETTINGS UP TO 20 MV FOR THE REOCOR S MODEL; AND 3) PROGRAMMABLE AV DELAY UP TO 400 MS. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES REOCOR S AND REOCOR D AND IS INDICATED FOR: TEMPORARY PACING; TEMPORARY TREATMENT OF ARRHYTHMIAS AND HEART BLOCK; SYMPTOMATIC SINUS BRADYCARDIA; PRE-, INTRA-, AN

510(k) clearances by this applicant