PMA P030054S298
- Device
- QUICKFLEX U AND QUARTET CRT LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S298
- Product code
- NIK
- Decision date
- 2016-02-17
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Update to the First Article Inspection procedure, an addition of pull testing of extruded tubing, a change in location for an extrusion process, and a change to the curing parameters of a polymer.
Current openFDA PMA Record#
- Device
- QUICKFLEX U AND QUARTET CRT LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S298
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-02-17
- Decision code
- OK30
- Date received
- 2016-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the First Article Inspection procedure, an addition of pull testing of extruded tubing, a change in location for an extrusion process, and a change to the curing parameters of a polymer.