HeartMate II Left Ventricular Assist System (LVAS)
FDA premarket approval P060040/S077 · decided 2020-04-09
Approval details
- PMA number
- P060040
- Supplement
- S077
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartMate II Left Ventricular Assist System (LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-03-16
- Decision date
- 2020-04-09
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Qualify an alternate sub-supplier for the polyester raw material used in the manufacture of the HeartMate II Apical Sewing Ring and Percutaneous Cable as well as the HeartMate 3 Percutaneous Cable.
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|---|---|---|
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| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |