Allure, Allure Quadra, and Quadra Allure MP
FDA premarket approval P030035/S180 · decided 2020-02-28
Approval details
- PMA number
- P030035
- Supplement
- S180
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Allure, Allure Quadra, and Quadra Allure MP
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-02-13
- Decision date
- 2020-02-28
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Adopt sterilization recipe Cycle PG 600 for the Abbott Penang Malaysia manufacturing facility.
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