PMA P880006S076
- Device
- Implantable Cardiac Pacemaker Pulse Generator
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S076
- Decision date
- 2012-04-13
Current openFDA PMA Record
- Device
- IMPLANTABLE CARDIAC PACEMAKER PULSE GENERATOR
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S076
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-04-13
- Decision code
- APPR
- Date received
- 2011-11-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.