PMA P030054S233
- Device
- QUICKSITE, QUICKFLEX, QUICKFLEX MICRO, QUARTET, PROMOTE, PROMOTE+, PROMOTE RF, PROMOTE ACCEL, PROMOTE Q,PROMOTE QUADRA
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S233
- Product code
- NIK
- Decision date
- 2012-10-10
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
Current openFDA PMA Record#
- Device
- QUICKSITE, QUICKFLEX, QUICKFLEX MICRO, QUARTET, PROMOTE, PROMOTE+, PROMOTE RF, PROMOTE ACCEL, PROMOTE Q,PROMOTE QUADRA
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S233
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-10-10
- Decision code
- OK30
- Date received
- 2012-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.