Allure Quadra, Quadra Allure MP, Frontier
FDA premarket approval P030035/S154 · decided 2017-10-20
Approval details
- PMA number
- P030035
- Supplement
- S154
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Allure Quadra, Quadra Allure MP, Frontier
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-02-07
- Decision date
- 2017-10-20
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Merlin Patient Care System (PCS) Model 3330 version 23.0.1 Software for the Merlin PCS Model 3650 Programmer.
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