PMA P030054S042
- Device
- EPIC HF FAMILY CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S042
- Product code
- NIK
- Decision date
- 2006-11-16
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- USE OF AN AUTOMATED SOLDERING PROCESS TO JOIN THE HV CAPACITOR WIRES TO THE HIGH VOLTAGE PRINTED CIRCUIT BOARD ASSEMBLY CONNECTOR PADS, AS AN ALTERNATE TO THE EXISTING MANUAL SOLDERING PROCESS.
Current openFDA PMA Record#
- Device
- EPIC HF FAMILY CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S042
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-11-16
- Decision code
- OK30
- Date received
- 2006-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN AUTOMATED SOLDERING PROCESS TO JOIN THE HV CAPACITOR WIRES TO THE HIGH VOLTAGE PRINTED CIRCUIT BOARD ASSEMBLY CONNECTOR PADS, AS AN ALTERNATE TO THE EXISTING MANUAL SOLDERING PROCESS.