PMA P030035S050
- Device
- ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S050
- Product code
- NKE
- Decision date
- 2009-01-16
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- CHANGES TO THE CLEANING PROCESS USED FOR FEEDTHROUGH AND HYBRID CERAMIC SUBSTRATES AT THE COMPONENT VENDOR.
Current openFDA PMA Record#
- Device
- ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S050
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2009-01-16
- Decision code
- OK30
- Date received
- 2008-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE CLEANING PROCESS USED FOR FEEDTHROUGH AND HYBRID CERAMIC SUBSTRATES AT THE COMPONENT VENDOR.