PMA P880086S105
- Device
- AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S105
- Product code
- DXY
- Decision date
- 2005-08-25
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- ADDITION OF A SPOT LASER WELD TO THE RESISTANCE WELD THAT BONDS THE FEEDTHROUGH WIRE TO THE CONNECTOR WIRE.
Current openFDA PMA Record#
- Device
- AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S105
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2005-08-25
- Decision code
- OK30
- Date received
- 2005-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SPOT LASER WELD TO THE RESISTANCE WELD THAT BONDS THE FEEDTHROUGH WIRE TO THE CONNECTOR WIRE.