PMA P880086S051
- Device
- AFFINITY DR & AFFINITY SR PULSE GENERATORS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S051
- Product code
- DXY
- Decision date
- 1999-01-21
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for the Model 3303 Software version 1.01 for use with the APS III Model 3500 Programmer.
Current openFDA PMA Record#
- Device
- AFFINITY DR & AFFINITY SR PULSE GENERATORS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S051
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 1999-01-21
- Decision code
- APPR
- Date received
- 1998-07-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Model 3303 Software version 1.01 for use with the APS III Model 3500 Programmer.