Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MR Conditional)
FDA premarket approval P030035/S187 · decided 2021-07-07
Approval details
- PMA number
- P030035
- Supplement
- S187
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MR Conditional)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-06-28
- Decision date
- 2021-07-07
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Adjust Bioburden action limit and alert levels at the Sylmar manufacturing site.
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |