PMA P030035S155
- Device
- Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S155
- Product code
- NKE
- Decision date
- 2017-03-30
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Use of a new sterilizer at the Sylmar, California facility.
Current openFDA PMA Record#
- Device
- Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S155
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2017-03-30
- Decision code
- OK30
- Date received
- 2017-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a new sterilizer at the Sylmar, California facility.