PMA P870072S019
- Device
- THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S019
- Product code
- DSQ
- Decision date
- 2002-04-18
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR ADDITION OF A CAUTION STATEMENT TO THE PACKAGE LABELING.
Current openFDA PMA Record#
- Device
- THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S019
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2002-04-18
- Decision code
- APPR
- Date received
- 2002-03-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITION OF A CAUTION STATEMENT TO THE PACKAGE LABELING.