PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U

FDA premarket approval P950037/S036 · decided 2004-03-31

Approval details

PMA number

P950037

Supplement

S036

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U

Generic name

implantable pacemaker Pulse-generator

Applicant

Biotronik, Inc.

Date received

2003-11-03

Decision date

2004-03-31

Days to decision

149 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR ADDITIONAL FEATURES ADDED TO THE PHILOS FAMILY OF PACEMAKERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS II AND IS INDICATED AS FOLLOWS: RATE-ADAPTIVE PACING WITH THE PHILOS II PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E.

510(k) clearances by this applicant