1 PDF document for PMA #1 and Test: Impedance testing PMA #2 (electrical test summary) Protocol Number: TRP300 Date of Initiation November 2, 2012 CH.3.3.1.2 Physical and Mechanical Full The design changes for PMA #3 include – – Report CoU keywords 1 PDF document for PMA #3 Test: Flex testing (fatigue test summary) Protocol Number: TRP2112 Date of Initiation: January 5, 2013 CH.3.3.1.2 Physical and Mechanical Full The design changes for PMA #1 and PMA – – Report #2 share the same CoU keywords: 1 PDF document for PMA #1 and PMA #2 Test: Impedance testing Filename: electrical test summary Protocol Number: TRP300 Date of Initiation: November 2, 2012 Package Changes COU and Document Keywords CH.3.3.10.2.1 Manufacturer Sterilization The sterilization share the same CoU – – Summary keywords: 1 PDF document for all PMAs Sterilization Method: EtO Filename: Sterilization Protocol Number: TRP9001 Date of Initiation: January 15, 2013 Labeling changes COU and Document Keywords CH.5.1 Labeling N/A – 1 PDF for Labeling for PMA #1 Filename: Label#1 CH.5.1 Labeling N/A – 1 PDF for Instructions for Use for PMA #1 Filename: IFU#1 CH.5.1 Labeling N/A – 1 PDF for Labeling for PMA #2 Filename: Label#2 CH.5.1 Labeling N/A – 1 PDF for Instructions for Use for PMA #2 Filename: IFU#2 CH.5.1 Labeling N/A – 1 PDF for Labeling for PMA #3 Filename: Label#3
1 PDF document for PMA #1 and PMA #2 (electrical test summary) Test: Impedance testing Protocol Number: TRP300 Date of Initiation November 2, 2012 CH.3.3.1.2 – Physical and Mechanical – Full Report 1 PDF document for PMA #3 (fatigue test summary) The design changes for PMA #3 include CoU keywords Test: Flex testing Protocol Number: TRP2112 Date of Initiation: January 5, 2013 CH.3.3.1.2 – Physical and Mechanical – Full Report 1 PDF document for PMA #1 and PMA #2 Filename: electrical test summary The design changes for PMA #1 and PMA #2 share the same CoU keywords: Test: Impedance testing Protocol Number: TRP300 Date of Initiation: November 2, 2012 Package Changes COU and Document Keywords CH.3.3.10.2.1 – Manufacturer Sterilization – Summary 1 PDF document for all PMAs Filename: Sterilization The sterilization share the same CoU keywords: Sterilization Method: EtO Protocol Number: TRP9001 Date of Initiation: January 15, 2013 Labeling changes COU and Document Keywords CH.5.1 – Labeling 1 PDF for Labeling for PMA #1 Filename: Label#1 N/A CH.5.1 – Labeling 1 PDF for Instructions for Use for PMA #1 Filename: IFU#1 N/A CH.5.1 – Labeling 1 PDF for Labeling for PMA #2 Filename: Label#2 N/A CH.5.1 – Labeling 1 PDF for Instructions for Use for PMA #2 Filename: IFU#2 N/A CH.5.1 – Labeling 1 PDF for Labeling for PMA #3 Filename: Label#3 N/A