PMA P100047S141
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S141
- Product code
- DSQ
- Decision date
- 2019-07-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Use of an electronic acceptable quality level (AQL) sampling feature within the Camstar Manufacturing Existing System (MES).
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S141
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-07-05
- Decision code
- OK30
- Date received
- 2019-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an electronic acceptable quality level (AQL) sampling feature within the Camstar Manufacturing Existing System (MES).