Platinium CRT-D 1741; Platinium 4LV CRT-D 1744
FDA premarket approval P060027/S094 · decided 2018-03-20
Approval details
- PMA number
- P060027
- Supplement
- S094
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Platinium CRT-D 1741; Platinium 4LV CRT-D 1744
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2018-02-26
- Decision date
- 2018-03-20
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Supplier manufacturing change for contact spring components assembled into headers.
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