Anesthesiology
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- P100047HEARTWARE VENTRICULAR ASSIST SYSTEMAPPRPMA Approval
- P060040THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEMAPPRPMA Approval
- P980012NOVACOR LVASAPWDPMA Approval
- P870072THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEMAPWDPMA Approval
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Abbott Medical
- Trade Name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Generic Name
- Ventricular (assist) bypass
- Decision Date
- 4/21/2008
- Days to Decision
- 486 days
- Decision Code
- APPR
- FDA Decision
- Approval