PMA P030054S071
- Device
- LEFT VENTRICULAR FAMILY OF LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S071
- Product code
- NIK
- Decision date
- 2007-10-31
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS.
Current openFDA PMA Record#
- Device
- LEFT VENTRICULAR FAMILY OF LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S071
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2007-10-31
- Decision code
- OK30
- Date received
- 2007-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS.