PMA P030054S349
- Device
- QuickFlex, Quartet
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S349
- Product code
- NIK
- Decision date
- 2018-03-20
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Implement a change to the Dexamethasone impurity limit for steroid eluting cardiac leads.
Current openFDA PMA Record#
- Device
- QuickFlex, Quartet
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S349
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-03-20
- Decision code
- OK30
- Date received
- 2018-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a change to the Dexamethasone impurity limit for steroid eluting cardiac leads.