PMA P100047S076
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S076
- Product code
- DSQ
- Decision date
- 2016-06-24
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Implementation of changes to the Splice Kit Assembly and the HVAD Large OD Sheath.
Current openFDA PMA Record#
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S076
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-06-24
- Decision code
- OK30
- Date received
- 2016-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of changes to the Splice Kit Assembly and the HVAD Large OD Sheath.