PMA P880086S075
- Device
- AFFINITY PULSE GENERATORS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S075
- Product code
- DXY
- Decision date
- 2000-08-15
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- APPROVAL FOR REMOVAL OF THE PARYLENE COATING FROM THE AFFINITY MODELS DR 5330, SR 5130, DC 5230, ENTITY DR 5326, AND ENTITY DC 5226 PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- AFFINITY PULSE GENERATORS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S075
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2000-08-15
- Decision code
- APPR
- Date received
- 2000-08-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REMOVAL OF THE PARYLENE COATING FROM THE AFFINITY MODELS DR 5330, SR 5130, DC 5230, ENTITY DR 5326, AND ENTITY DC 5226 PULSE GENERATORS.