PMA P100047S148
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S148
- Product code
- DSQ
- Decision date
- 2019-10-18
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Modifications to the assembly process for the Apical Coring Tool.
Current openFDA PMA Record#
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S148
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-10-18
- Decision code
- OK30
- Date received
- 2019-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the assembly process for the Apical Coring Tool.