Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF
FDA premarket approval P030035/S166 · decided 2018-02-22
Approval details
- PMA number
- P030035
- Supplement
- S166
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-01-31
- Decision date
- 2018-02-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Adjust the relative humidity in the device and leads manufacturing and product packaging areas located in the Sylmar, California facility.
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