AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS

FDA premarket approval P880086/S050 · decided 1999-01-22

Approval details

PMA number

P880086

Supplement

S050

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS

Generic name

implantable pacemaker Pulse-generator

Applicant

ABBOTT MEDICAL

Date received

1998-07-30

Decision date

1999-01-22

Days to decision

176 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

Approval for the Affinity DR Model 5330 L/R Dual-Chamber and Affinity SR Model 5130 L/R Single-Chamber Rate-Adaptive Pulse Generators with AutoCapture. The devices, as modified, will be marketed under the trade Affinity DR Model 5330 L/R and Affinity Sr Model 5130 L/R and are indicated for rate-adaptive support pacing.

510(k) clearances by this applicant