CORCYM S.r.l.

PMA#

• Carbomedics® Prosthetic Heart Valve, Carbomedics® Supra-annular Prosthetic Heart Valve (Top Hat), Carbo-Seal® Ascending

  2022-03-07

  CORCYM S.r.l.via Crescentino, Snsaluggia 13040 PMA NumberP900060 Supplement NumberS064 Date Received02/07/2022 Decision Date03/07/2022 Product Code LWQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufa...

• Carbomedics Prosthetic Heart Valve (CPHV)

  2021-09-09

  CORCYM S.r.l.

PMN#

• Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring

  2023-04-07

  Corcym S.r.l.

GUDID#

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• Memo 4D Curve - The Memo 4D Curve is a semirigid open mitral annuloplasty ring

  CORCYM SRL

  2026-07-04

• JOSEPH LAMELAS Atrial Lift System - The JOSEPH LAMELAS Atrial Lift System device is a set of 4 disposable surgical instrument components packaged together as a system for use as a single surgical instrument for atrial wall tissue retraction.

  CORCYM SRL

  2026-02-03

• CUFF Aortic Root Exposure Device - The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root and used to retract aortic wall tissue. The device consists of a main body component with retraction wings which are two-tiered and extend laterally. The posterior aspect of the device has a stabilization flange along the inferior border. Two alignment suture eyelet holes can be found within the medial portion of the stabilization flange.

  CORCYM SRL

  2026-02-03

• SUTURE BELT Circumferential Suture Organizer - The Suture Belt device is a circumferential surgical suture organizer that mounts to a retractor rack prior to use. The device incorporates a rigid base frame with 24 flexible holding plug inserts that receive and retain suture pairs. Suture retention is achieved by pressing the suture strands into the compression slots found between the rigid base frame and flexible holding plug inserts. The rigid base frame consists of 2 hinged halves which allow for angle adjustment of the individual segments. The attachment arms allow the device to be mounted to the retractor arms. Two spacer components allow the attachment arm height to be adjusted. The device is secured into the desired orientation and segment angle positioning by tightening the immobilizing thumb screws.

  CORCYM SRL

  2026-02-03

• TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle Exposure - The TIE device is a tourniquet-style surgical instrument used to control the target location of knot seating during precise suture knot tying and delivery applications. The COLLAR device is a flexible surgical retractor designed to retract valve leaflet tissue when inserted within the valve annulus. The device consists of a main body component which extends laterally to become the retraction wings. The distal tips of the retraction wings are bifurcated for additional tissue traction. The posterior aspect of the device has a stiffening rib along the superior border and a stabilization flange along the inferior border. The COLLAR device is available in 2 sizes (small and large) which are packaged together in a disposable set with the TIE device.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Knot Pusher - The JOSEPH LAMELAS Knot Pusher is a disposable surgical instrument used to advance throws of extracorporeal knots to an intracorporeal object contained within a small cavity.

  CORCYM SRL

  2026-02-03

• DeTACH Aortic Cross Clamp Head-Large - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device

  CORCYM SRL

  2026-02-03

• DeTACH Aortic Cross Clamp Head-Small - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Atrial Lift System - The JOSEPH LAMELAS Atrial Lift System device is a set of 4 disposable surgical instrument components packaged together as a system for use as a single surgical instrument for atrial wall tissue retraction.

  CORCYM SRL

  2026-02-03

• CUFF Aortic Root Exposure Device - The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root and used to retract aortic wall tissue. The device consists of a main body component with retraction wings which are two-tiered and extend laterally. The posterior aspect of the device has a stabilization flange along the inferior border. Two alignment suture eyelet holes can be found within the medial portion of the stabilization flange.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Intercostal Retractor System Kit - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Intercostal Retractor System Retractor Rack - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Intercostal Retractor System Small Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Intercostal Retractor System Medium Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Intercostal Retractor System Large Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Intercostal Retractor System Extra Large Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Intercostal Retractor System Small Double Swivel Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Intercostal Retractor System Medium Double Swivel Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Intercostal Retractor System Sterilization Tray - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

  CORCYM SRL

  2026-02-03

• SUTURE BELT Circumferential Suture Organizer - The Suture Belt device is a circumferential surgical suture organizer that mounts to a retractor rack prior to use. The device incorporates a rigid base frame with 24 flexible holding plug inserts that receive and retain suture pairs. Suture retention is achieved by pressing the suture strands into the compression slots found between the rigid base frame and flexible holding plug inserts. The rigid base frame consists of 2 hinged halves which allow for angle adjustment of the individual segments. The attachment arms allow the device to be mounted to the retractor arms. Two spacer components allow the attachment arm height to be adjusted. The device is secured into the desired orientation and segment angle positioning by tightening the immobilizing thumb screws.

  CORCYM SRL

  2026-02-03

• TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle Exposure - The TIE device is a tourniquet-style surgical instrument used to control the target location of knot seating during precise suture knot tying and delivery applications. The COLLAR device is a flexible surgical retractor designed to retract valve leaflet tissue when inserted within the valve annulus. The device consists of a main body component which extends laterally to become the retraction wings. The distal tips of the retraction wings are bifurcated for additional tissue traction. The posterior aspect of the device has a stiffening rib along the superior border and a stabilization flange along the inferior border. The COLLAR device is available in 2 sizes (small and large) which are packaged together in a disposable set with the TIE device.

  CORCYM SRL

  2026-02-03

• JOSEPH LAMELAS Knot Pusher - The JOSEPH LAMELAS Knot Pusher is a disposable surgical instrument used to advance throws of extracorporeal knots to an intracorporeal object contained within a small cavity.

  CORCYM SRL

  2026-02-03

• DeTACH Aortic Cross Clamp Head-Large - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device

  CORCYM SRL

  2026-02-03

• DeTACH Aortic Cross Clamp Head- Medium - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device

  CORCYM SRL

  2026-02-03

• DeTACH Aortic Cross Clamp Head-Small - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device

  CORCYM SRL

  2026-02-03

• DeTACH Aortic Cross Clamp Delivery System - The DeTACH Delivery System is a reusable delivery and retrieval system for the DeTACH Detachable Aortic Cross Clamp Head device. The kit includes the Delivery Device, Quick Release Device, and Sterilization Tray.

  CORCYM SRL

  2026-02-03

• DeTACH Aortic Cross Clamp Quick Release Device - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Quick Release.

  CORCYM SRL

  2026-02-03

• DeTACH Aortic Cross Clamp Sterilization Tray - The Sterilization Tray is comprised of a lid and a base component. The sterilization tray base has been preconfigured with receiving slots for the Delivery Device and Quick Release Device accessory components.

  CORCYM SRL

  2026-02-03

• DeTACH Aortic Cross Clamp Delivery Device - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device

  CORCYM SRL

  2026-02-03

• PERCEVAL S - ICV1232

  CORCYM SRL

  2016-06-06

• PERCEVAL S - ICV1148

  CORCYM SRL

  2016-06-06

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