← FDA Medical Device Classifications

Heart-Valve, Non-Allograft Tissue

LWR · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code

LWR

Device class

Class III — High Risk (PMA approval required, life-sustaining)

Regulation

—

Review panel

CV

Medical specialty

Unknown

Submission type

2

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

0

Registered establishments

20

Source

Authoritative

FDA Device Classification database

Machine

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