PMA P920014S020
- Device
- THORATEC HEARTMATE STROKE VOLUME LIMITER
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S020
- Product code
- DSQ
- Decision date
- 2003-03-21
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR SPECIFIC ADDITIONAL SAFETY INSTRUCTIONS TO THE LABELING FOR THE STROKE VOLUME LIMITER.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE STROKE VOLUME LIMITER
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S020
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2003-03-21
- Decision code
- APPR
- Date received
- 2003-02-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR SPECIFIC ADDITIONAL SAFETY INSTRUCTIONS TO THE LABELING FOR THE STROKE VOLUME LIMITER.