PMA P100047S055
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S055
- Product code
- DSQ
- Decision date
- 2015-03-25
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR AN ADDITIONAL INDEPENDENT INSPECTION AT FINAL PACKAGING.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S055
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2015-03-25
- Decision code
- APPR
- Date received
- 2015-02-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL INDEPENDENT INSPECTION AT FINAL PACKAGING.