PMA P030054S013
- Device
- IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S013
- Product code
- NIK
- Decision date
- 2005-11-02
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- ALTERNATE MANUFACTURING PROCESS CHANGE TO ALLOW COMPONENT CURING IN AN AUTOCLAVE SYSTEM, WITH SUBSEQUENT REDUCTION IN PROCESS TIME.
Current openFDA PMA Record#
- Device
- IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S013
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2005-11-02
- Decision code
- OK30
- Date received
- 2005-10-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE MANUFACTURING PROCESS CHANGE TO ALLOW COMPONENT CURING IN AN AUTOCLAVE SYSTEM, WITH SUBSEQUENT REDUCTION IN PROCESS TIME.