PMA P060040S020
- Device
- THORATEC HEARTMATE II VAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S020
- Product code
- DSQ
- Decision date
- 2012-05-31
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- CHANGES TO THE SUPPLIER WHO MANUFACTURES THE HEARTMATE II LVAS BATTERIES.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II VAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S020
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2012-05-31
- Decision code
- OK30
- Date received
- 2012-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE SUPPLIER WHO MANUFACTURES THE HEARTMATE II LVAS BATTERIES.