PMA P870072S015
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S015
- Product code
- DSQ
- Decision date
- 2001-11-30
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR THE ISSUANCE OF TECHNICAL BULLETIN #009.
Current openFDA PMA Record#
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S015
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2001-11-30
- Decision code
- APPR
- Date received
- 2001-06-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ISSUANCE OF TECHNICAL BULLETIN #009.