PMA P030054S323
- Device
- QuickFlex u and Quartet leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S323
- Product code
- NIK
- Decision date
- 2018-04-02
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Approval for an alternate supplier for material used for lead insulation tubing.
Current openFDA PMA Record#
- Device
- QuickFlex u and Quartet leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S323
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-04-02
- Decision code
- APPR
- Date received
- 2017-02-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate supplier for material used for lead insulation tubing.