PMA P100047S069
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S069
- Product code
- DSQ
- Decision date
- 2015-12-15
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- TO ADD A SUPPLIER FOR A CRITICAL COMPONENT, WHERE THE SPECIFICATIONS ARE UNCHANGED.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S069
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2015-12-15
- Decision code
- OK30
- Date received
- 2015-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO ADD A SUPPLIER FOR A CRITICAL COMPONENT, WHERE THE SPECIFICATIONS ARE UNCHANGED.