PMA P100047S049
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S049
- Product code
- DSQ
- Decision date
- 2014-10-16
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR CHANGING THE HEAT SEAL ADHESIVE COATING ON THE INNER AND OUTER TRAYS OF THE IMPLANT KIT/ IMPLANT ACCESSORIES AND SURGICAL TOOLS.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S049
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-10-16
- Decision code
- APPR
- Date received
- 2014-08-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGING THE HEAT SEAL ADHESIVE COATING ON THE INNER AND OUTER TRAYS OF THE IMPLANT KIT/ IMPLANT ACCESSORIES AND SURGICAL TOOLS.