PMA P880086S078
- Device
- INTEGRITY AFX DR/INTEGRITY SR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S078
- Product code
- DXY
- Decision date
- 2000-10-02
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142.
Current openFDA PMA Record#
- Device
- INTEGRITY AFX DR/INTEGRITY SR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S078
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2000-10-02
- Decision code
- APPR
- Date received
- 2000-09-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142.