PMA P880086S278
- Device
- PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM1152, PM2152
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S278
- Product code
- DXY
- Decision date
- 2017-02-24
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Modifications to the dry buffing process used on device headers.
Current openFDA PMA Record#
- Device
- PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM1152, PM2152
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S278
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2017-02-24
- Decision code
- OK30
- Date received
- 2017-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the dry buffing process used on device headers.