Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON SENOFILCON A BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·QUICKSITE FAMILY OF LEADS-MODELS 1056K, 1056T AND 1058T & QUICKFLEX FAMILY OF LEADS-MODELS 1156T AND 1158T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELECT MODELS OF SYNCHRONY, TRILOGY AND AFFINITY FAMILY OF PACEMAKERS, SOLUS,ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, Y

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony PLUS Extended Range of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range of

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 FAMILY OF CRT-D'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF CRT-D'S (INCEPTA, ENERGEN, & PUNCTUA)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINTY/IDENTITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·SNS URINARY INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF PASYS, SPECTRAX, SYMBIOS, SYNERGYST

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE Family of ENDOCARDIAL PACING LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE/ ELLIPSE/ FORTIFY ASSURA FAMILY OF ICDS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS AND CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY AND ENDURITY CORE FAMILY OF PACEMAKERS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II / THINLINE II FAMILY OF LEADS