PMA P100047S041
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S041
- Product code
- DSQ
- Decision date
- 2014-04-04
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- MODIFICATIONS TO THE COATING PROCESS FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S041
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-04-04
- Decision code
- OK30
- Date received
- 2014-03-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATIONS TO THE COATING PROCESS FOR THE DEVICE.