PMA P030054S371
- Device
- Quadra Assura, Unify, Unify Assura and Unify Quadra CRT-D
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S371
- Product code
- NIK
- Decision date
- 2019-10-15
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Modify the temperature range utilized for the temperature cycling of hybrid assemblies with organic substrates.
Current openFDA PMA Record#
- Device
- Quadra Assura, Unify, Unify Assura and Unify Quadra CRT-D
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S371
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-10-15
- Decision code
- OK30
- Date received
- 2019-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the temperature range utilized for the temperature cycling of hybrid assemblies with organic substrates.