SOLOX VDD PACING LEAD

FDA premarket approval P950037/S024 · decided 2003-04-23

Approval details

PMA number

P950037

Supplement

S024

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SOLOX VDD PACING LEAD

Generic name

permanent pacemaker Electrode

Applicant

Biotronik, Inc.

Date received

2001-12-31

Decision date

2003-04-23

Days to decision

478 days

Decision code

APPR

Product code

DTB

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR THE SOLOX VDD PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOLOX VDD PACING LEAD AND IS INDICATED AS FOLLOWS: THE SOLOX LEAD IS INDICATED FOR USE AS PART OF A SYSTEM ONLY. THE SYSTEM INCLUDES ANY OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS AND THE SOLOX VDD LEAD. THEREFORE, THE INDICATIONS FOR THE SOLOX VDD LEAD ARE IDENTICAL TO THE INDICATIONS FOR USE OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS. BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS

510(k) clearances by this applicant