PMA P030035S190
- Device
- Allure Quadra
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S190
- Product code
- NKE
- Decision date
- 2022-07-14
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Second-tier supplier's manufacturing site transfer.
Current openFDA PMA Record#
- Device
- Allure Quadra
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S190
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-07-14
- Decision code
- OK30
- Date received
- 2022-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second-tier supplier's manufacturing site transfer.