PMA P100047S014
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S014
- Product code
- DSQ
- Decision date
- 2013-05-15
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT HEARTWARE IN MIAMI LAKES, FLORIDA.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S014
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-05-15
- Decision code
- APPR
- Date received
- 2012-12-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT HEARTWARE IN MIAMI LAKES, FLORIDA.