PMA P030035S180
- Device
- Allure, Allure Quadra, and Quadra Allure MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S180
- Product code
- NKE
- Decision date
- 2020-02-28
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Adopt sterilization recipe Cycle PG 600 for the Abbott Penang Malaysia manufacturing facility.
Current openFDA PMA Record#
- Device
- Allure, Allure Quadra, and Quadra Allure MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S180
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-02-28
- Decision code
- OK30
- Date received
- 2020-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adopt sterilization recipe Cycle PG 600 for the Abbott Penang Malaysia manufacturing facility.