Medical Device Manufacturer · US , Mchenry , IL

Pacesetter Systems - FDA 510(k) Cleared Devices

96 submissions · 96 cleared · Since 1976

96

Total

96

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pacesetter Systems General Hospital ✕

8 devices

1-8 of 8

Cleared Jun 09, 1986

SOF SET, MODELS 111 AND 112

General Hospital · 53d

Cleared May 27, 1986

SOF SET, MODELS 113 AND 114

General Hospital · 81d

Cleared Jan 22, 1985

MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A

General Hospital · 43d

Cleared Jan 22, 1985

MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504

General Hospital · 40d

Cleared Sep 12, 1983

SINGLE USE SYRINGE #103 PERSONAL MEDIC

General Hospital · 130d

Cleared Sep 12, 1983

INFUSION SETS #'S 124 & 142 PERSONAL

General Hospital · 130d

Cleared Mar 24, 1983

PERSONAL MEDICATION INFUSER

General Hospital · 30d

Cleared Nov 06, 1981

PERSONAL MEDICATION INFUSER

General Hospital · 221d