PMA P100047S095
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S095
- Product code
- DSQ
- Decision date
- 2017-06-27
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Implementation of new visual criteria and inspection for particulates in the packaging trays of HVAD components.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S095
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-06-27
- Decision code
- OK30
- Date received
- 2017-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of new visual criteria and inspection for particulates in the packaging trays of HVAD components.