OPTISENSE MODEL 1699T/TC LEADS

FDA premarket approval P960013/S025 · decided 2007-05-07

Approval details

PMA number

P960013

Supplement

S025

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

OPTISENSE MODEL 1699T/TC LEADS

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2006-11-30

Decision date

2007-05-07

Days to decision

158 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE OPTISENSE MODEL 1699T AND 1699TC LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPTISENSE MODEL 1699T AND 1699TC LEADS AND ARE DESIGNED FOR PERMANENT SENSING AND PACING IN THE RIGHT ATRIUM, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. AN ACTIVE FIXATION LEAD SUCH AS THE MODEL 1699 MAY BE INDICATED FOR PATIENTS WHERE PERMANENT FIXATION OF PASSIVE LEADS IS SUSPECTED TO BE UNSTABLE. IN ATRIAL APPLICATIONS, THE USE OF A SCREW-IN LEAD MAY BE INDICATED IN T

510(k) clearances by this applicant