PMA P030054S073
- Device
- EPIC HF FAMILY CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S073
- Product code
- NIK
- Decision date
- 2007-12-19
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) REPLACE THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITH PLUG/RECEPTACLE CONNECTORS; 2) AN ORGANIC SUBSTRATE WILL BE USED FOR THE HYBRID MODULE; AND 3) DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS WERE RE-CONFIGURED INTO SURFACE-MOUNTABLE PACKAGES.
Current openFDA PMA Record#
- Device
- EPIC HF FAMILY CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S073
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2007-12-19
- Decision code
- APPR
- Date received
- 2007-10-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) REPLACE THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITH PLUG/RECEPTACLE CONNECTORS; 2) AN ORGANIC SUBSTRATE WILL BE USED FOR THE HYBRID MODULE; AND 3) DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS WERE RE-CONFIGURED INTO SURFACE-MOUNTABLE PACKAGES.