EXCOR Pediatric Ventricular Assist Device
FDA premarket approval P160035/S001 · decided 2018-05-21
Approval details
- PMA number
- P160035
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- EXCOR Pediatric Ventricular Assist Device
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2017-06-29
- Decision date
- 2018-05-21
- Days to decision
- 326 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval of the protocol for the post-approval study protocol.
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