Medical Device Manufacturer · US , Sylmar , CA

Pacesetter, Inc. - FDA 510(k) Cleared Devices

8 submissions · 2 cleared · Since 1995

8

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pacesetter, Inc. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Feb 23, 1998

LOCATOR MODEL 4036

Cardiovascular · 209d

Cleared Feb 01, 1996

AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)

Cardiovascular · 122d

Cleared Dec 26, 1995

DF-1 TERMINAL CAP

Cardiovascular · 85d

Cleared Aug 31, 1995

PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

Cardiovascular · 127d

Cleared Aug 31, 1995

PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

Cardiovascular · 113d

Cleared Jun 29, 1995

TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD

Cardiovascular · 112d

Cleared Apr 06, 1995

IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069

Cardiovascular · 83d