PMA P030054S183
- Device
- FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S183
- Product code
- NIK
- Decision date
- 2011-05-10
- 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 TIGHTER SCREENING LIMITS AND THE INCLUSION OF A REFLOW THERMAL CONDITIONING DURING THE MANUFACTURE OF TANTALUM CAPACITOR COMPONENTS.
Current openFDA PMA Record#
- Device
- FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S183
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2011-05-10
- Decision code
- APPR
- Date received
- 2011-03-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR TIGHTER SCREENING LIMITS AND THE INCLUSION OF A REFLOW THERMAL CONDITIONING DURING THE MANUFACTURE OF TANTALUM CAPACITOR COMPONENTS.