PMA P030054S366
- Device
- QuickFlex u, Quartet Cardiac Resynchronization Therapy (CRT) Passive Fixation Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S366
- Product code
- NIK
- Decision date
- 2018-12-05
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Introduce periodic particulate matter testing and equipment to the Malaysia and Puerto Rico manufacturing facilities.
Current openFDA PMA Record#
- Device
- QuickFlex u, Quartet Cardiac Resynchronization Therapy (CRT) Passive Fixation Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S366
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-12-05
- Decision code
- OK30
- Date received
- 2018-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce periodic particulate matter testing and equipment to the Malaysia and Puerto Rico manufacturing facilities.