PMA P100047S004
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S004
- Product code
- DSQ
- Decision date
- 2013-01-04
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- USE OF AN ADDITIONAL ETHYLENE OXIDE STERILIZATION CHAMBER AT STERIGENICS, LOCATED IN SALT LAKE CITY, UTAH.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S004
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-01-04
- Decision code
- OK30
- Date received
- 2012-11-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN ADDITIONAL ETHYLENE OXIDE STERILIZATION CHAMBER AT STERIGENICS, LOCATED IN SALT LAKE CITY, UTAH.