PMA P880086S267
- Device
- ASSURITY AND ENDURITY CORE FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S267
- Product code
- NVZ
- Decision date
- 2016-01-30
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR AN ALTERNATE HYBRID ASSEMBLY FOR USE IN THE DEVICES.
Current openFDA PMA Record#
- Device
- ASSURITY AND ENDURITY CORE FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S267
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2016-01-30
- Decision code
- APPR
- Date received
- 2015-12-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATE HYBRID ASSEMBLY FOR USE IN THE DEVICES.