PMA P880086S274
- Device
- Assurity - PM1240, PM2240, Assurity+ - PM1260, PM2260, Endurity - PM1160, PM2160, Endurity Core - PM1152, PM2152
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S274
- Product code
- DXY
- Decision date
- 2016-08-19
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Alternate supplier of pacemaker case halves.
Current openFDA PMA Record#
- Device
- Assurity - PM1240, PM2240, Assurity+ - PM1260, PM2260, Endurity - PM1160, PM2160, Endurity Core - PM1152, PM2152
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S274
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2016-08-19
- Decision code
- OK30
- Date received
- 2016-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier of pacemaker case halves.