PMA P030035S185
- Device
- Allure, Allure Quadra, Quadra Allure MP and Quadra Allure (MRI Conditional)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S185
- Product code
- NKE
- Decision date
- 2021-04-09
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Adjust sample size for bacterial endotoxin testing.
Current openFDA PMA Record#
- Device
- Allure, Allure Quadra, Quadra Allure MP and Quadra Allure (MRI Conditional)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S185
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2021-04-09
- Decision code
- OK30
- Date received
- 2021-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust sample size for bacterial endotoxin testing.