PMA P870072S029
- Device
- THORATEC PVAD SYSTEM AND TLC-II PORTABLE VAD DRIVER
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S029
- Product code
- DSQ
- Decision date
- 2004-09-13
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR THE POST APPROVAL STUDY HOME-DISCHARGE REGISTRY PROTOCOL.
Current openFDA PMA Record#
- Device
- THORATEC PVAD SYSTEM AND TLC-II PORTABLE VAD DRIVER
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S029
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2004-09-13
- Decision code
- APPR
- Date received
- 2004-02-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR THE POST APPROVAL STUDY HOME-DISCHARGE REGISTRY PROTOCOL.