ABSORB Bioresorbable Vascular Scaffold System

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog Number: Absorb: 1012462-08, 1012462-12, 1012462-18, 1012462-23, 1012462-28, 1012463-08, 1012463-12, 1012463-18, 1012463-23, 1012463-28, 1012464-12, 1012464-18, 1012464-23, 1012464-28 Absorb GT1: 1234250-08, 1234250-12, 1234250-18, 1234250-23, 1234250-28, 1234300-08-1234300-12, 1234300-18, 1234300-23,1234300-28, 1234350-12, 1234350-18, 1234350-23, 1234350-28 Model Number: Absorb: 1012462-08, 1012462-12, 1012462-18, 1012462-23, 1012462-28, 1012463-08, 1012463-12, 1012463-18, 1012463-23, 1012463-28, 1012464-12, 1012464-18, 1012464-23, 1012464-28 Absorb GT1: 1234250-08, 1234250-12, 1234250-18, 1234250-23, 1234250-28, 1234300-08-1234300-12, 1234300-18, 1234300-23,1234300-28, 1234350-12, 1234350-18, 1234350-23, 1234350-28 Batch Number: Všechny
  • Product Classification
  • Product Description
    Inactive implantable medical devices
  • Manufacturer
  • Model / Serial
    1012462-08, 1012462-12, 1012462-18, 1012462-23, 1012462-28, 1012463-08, 1012463-12, 1012463-18, 1012463-23, 1012463-28, 1012464-12, 1012464-18, 1012464-23, 1012464-28 | All
  • Product Description
    MD: Bioabsorbable coronary artery stent, drug-eluting
  • Manufacturer
  • Model / Serial
    Model Catalog: 1012463-23 (Lot serial: ALL LOTS); Model Catalog: 1012464-28 (Lot serial: ALL LOTS); Model Catalog: 1012464-23 (Lot serial: ALL LOTS); Model Catalog: 1012464-18 (Lot serial: ALL LOTS); Model Catalog: 1012464-12 (Lot serial: ALL LOTS); Model Catalog: 1012463-28 (Lot serial: ALL LOTS); Model Catalog: 1012462-12 (Lot serial: ALL LOTS); Model Catalog: 1012463-18 (Lot serial: ALL LOTS); Model Catalog: 1012463-12 (Lot serial: ALL LOTS); Model Catalog: 1012462-28 (Lot serial: ALL LOTS); Model Catalog: 1012462-23 (Lot serial: ALL LOTS); Model Catalog: 1012462-18 (Lot serial: ALL LOTS)
  • Product Description
    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVS)
  • Manufacturer