PMA P870072S058
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD)
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S058
- Product code
- DSQ
- Decision date
- 2013-12-19
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- USE OF A NEW COULOMETER IN THE MANUFACTURE OF THE POLYMER MATERIAL.
Current openFDA PMA Record#
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD)
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S058
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-12-19
- Decision code
- OK30
- Date received
- 2013-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF A NEW COULOMETER IN THE MANUFACTURE OF THE POLYMER MATERIAL.