PMA P870072S010
- Device
- THORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S010
- Product code
- DSQ
- Decision date
- 2000-11-15
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A SURGICAL IMPLANT ACCESSORY KIT WITH THE FOLLOWING ACCESSORIES: VENTRICULAR CANNULA VENTING CONNECTOR, VALVE HOUSING CAPS, CANNULA PLUGS, ATRIAL CANNULA TIP CAP, AND Y-CONNECTOR CAP. THE ACCESSORY KIT WILL BE MANUFACTURED AT HORIZON MEDICAL, INC., SANTA ANA, CALIFORNIA, AND STERILIZED BY STERIGENICS, TUSTIN, CALIFORNIA.
Current openFDA PMA Record#
- Device
- THORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S010
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2000-11-15
- Decision code
- APPR
- Date received
- 2000-04-11
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR A SURGICAL IMPLANT ACCESSORY KIT WITH THE FOLLOWING ACCESSORIES: VENTRICULAR CANNULA VENTING CONNECTOR, VALVE HOUSING CAPS, CANNULA PLUGS, ATRIAL CANNULA TIP CAP, AND Y-CONNECTOR CAP. THE ACCESSORY KIT WILL BE MANUFACTURED AT HORIZON MEDICAL, INC., SANTA ANA, CALIFORNIA, AND STERILIZED BY STERIGENICS, TUSTIN, CALIFORNIA.