HeartWare Ventricular Assist System
FDA premarket approval P100047/S141 · decided 2019-07-05
Approval details
- PMA number
- P100047
- Supplement
- S141
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartWare Ventricular Assist System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2019-06-10
- Decision date
- 2019-07-05
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Use of an electronic acceptable quality level (AQL) sampling feature within the Camstar Manufacturing Existing System (MES).
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