Changes

== Medical Devices ==

== Medical Devices ==

=== MD_INS_CASE_CAPA ===

=== MD_INS_CASE_CAPA ===

|Yes

|Yes

|NULL

|NULL

|February 13, 2024 The company is having the manufacturer of the rescue

|The inspector sent follow-up letter to address Physio-controls response--the manufacturer can have more than one ID on the label as long as it clearly marks what the device identifier is and that this identifier matches what is in the MDALL. March 6, 2024 The company sent follow-up from manufacturer.  The manufacturer has sent in a fax back to Health Canada to include the device ID (11141-000165) under their license. This adequately addresses the observation.

 

kits provide labels.  The manufacturer (Physio Control Inc) of the lifepakbatteries felt that they did not need to address the labelling as theywere under the understanding that as a replacement the battery fell underthe original kit.February 19, 2024 The inspector sent follow-up letter to addressPhysio-controls response--the manufacturer can have more than one ID onthe label as long as it clearly marks what the device identifier is andthat this identifier matches what is in the MDALL.March 6, 2024 The company sent follow-up from manufacturer.  Themanufacturer has sent in a fax back to Health Canada to include the deviceID (11141-000165) under their license. This adequately addresses theobservation

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