HEARTMATE II LVAS
FDA premarket approval P060040/S033 · decided 2014-04-03
Approval details
- PMA number
- P060040
- Supplement
- S033
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HEARTMATE II LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-03-07
- Decision date
- 2014-04-03
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE AND THE PATIENT HANDBOOK.
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