ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251

FDA 510(k)

FDA Class 3 ·Cardiovascular

AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA

FDA 510(k)

FDA Class 3 ·Cardiovascular

AMS LARGE PORE POLYPROPYLENE MESH

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

AMS PERIGEE SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

OPUS MODEL 4021, VVI, 5MM UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

POWERHEART AED G3A

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 5301B TEST CABLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)

FDA 510(k)

FDA Class 3 ·Cardiovascular

ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED

FDA 510(k)

FDA Class 3 ·Cardiovascular

ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC 5984-5984LP-5985

FDA 510(k)

FDA Class 3 ·Cardiovascular