Biotronik Plexa ProMRI ICD lead

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

BIOTRONIK ASIA PACIFIC PTE. LTD.

Class:

Class D (contains therapeutic product or medicinal product)

Manufactured by:

BIOTRONIK SE & Co. KG

Therapeutic area:

Cardiovascular

Therapeutic indications:

In combination with compatible ICD, this lead is designed for the following: permanent sensing and pacing in the right ventricle; delivery of defibrillation/cardioversion therapies. With its active fixation screw, this lead is especially suitable for patients with degenerated trabeculae in the ventricle for whom passive fixation with silicone or polyurethane tines is not possible. Plexa DF-1 S DX leads; Plexa S DX 65/15 and Plexa S Dx 65/17 are also designed for permanent sensing in the right atrium. ICD leads with two dipoles for sensing in both chambers are especially indicated for patients who, in addition to the usual ICD indications, have documented paroxysmal atrial fibrillation.

Product summary:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], Leads and associated accessories (e.g. stylets, fixation tools). Sterilized by EO.; Models: Plexa ProMRI SD 65/16 - 402262, Plexa ProMRI SD 65/18 - 402263, Plexa ProMRI SD 75/18 - 402264, Plexa ProMRI S 65 - 402266, Plexa ProMRI S 75 - 402267, Plexa ProMRI DF-1 SD 65/16 - 414000, Plexa ProMRI DF-1 SD 65/18 - 414001, Plexa ProMRI DF-1 SD 75/18 - 414002, Plexa ProMRI DF-1 S 65 - 413997, Plexa ProMRI DF-1 S 75 - 413998, Plexa ProMRI DF-1 S DX 65/15 - 414005, Plexa ProMRI DF-1 S DX 65/17 - 414006, S 60 C (10 pieces) - 359223, S 60 C (1 piece) - 395096, S 60 K (10 pieces) - 106162, S 60 K (1 piece) - 395104, S 65-C (10 pieces) - 342657, S 65-C (1 piece) - 395098, S 65-K (10 pieces) - 117464, S 65-K (1 piece) - 395099, S 75-C (10 pieces) - 124301, S 75-C (1 piece) - 395101, S 75-K (10 pieces) - 121197, S 75-K (1 piece) - 395106, DH DF4 (10 pieces) - 379137, DH DF4 (2 pieces) - 395402, DH (10 pieces) - 331668, DH (2 pieces) - 395111, DH IS-1/DF4 (10 pieces) - 401298, DH IS-1/DF4 (2 pieces) - 401297, EFH-8F-W (5 pieces) - 401014, EFH-8F-W (1 piece) - 401015, IS4/DF4-Adapter (5 pieces) - 412302, IS4/DF4-Adapter (1 piece) - 412303, Vein lifter - 371805, Plexa ProMRI S DX 65/15 - 436909, Plexa ProMRI S DX 65/17 - 436910, BK-IS - 109185, Plexa ProMRI SD 60/16 - 402261, Plexa ProMRI S 60 - 402265, Plexa ProMRI DF-1 SD 60/16 - 413999, Plexa ProMRI DF-1 S 60 - 413996

Authorization date:

2019-02-21