PMA P100047S037
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S037
- Product code
- DSQ
- Decision date
- 2014-03-13
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE SUPPLIER FOR THE NON-PATIENT CONTACTING PATCH MATERIAL USED IN THE HEARTWARE® VENTRICULAR ASSIST SYSTEM.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S037
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-03-13
- Decision code
- OK30
- Date received
- 2014-02-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE SUPPLIER FOR THE NON-PATIENT CONTACTING PATCH MATERIAL USED IN THE HEARTWARE® VENTRICULAR ASSIST SYSTEM.