PMA P030054S319
- Device
- CD3231-40, CD3231-40Q, CD3257-40, CD3257-40Q, CD3357-40, CD3357-40C, CD3357-40Q, CD3357-40QC,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S319
- Product code
- NIK
- Decision date
- 2017-02-24
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Modifications to the dry buffing process used on device headers.
Current openFDA PMA Record#
- Device
- CD3231-40, CD3231-40Q, CD3257-40, CD3257-40Q, CD3357-40, CD3357-40C, CD3357-40Q, CD3357-40QC,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S319
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-02-24
- Decision code
- OK30
- Date received
- 2017-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the dry buffing process used on device headers.