REPEL-CV BIORESORBABLE ADHESION BARRIER
FDA premarket approval P070005/S003 · decided 2014-04-30
Approval details
- PMA number
- P070005
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- REPEL-CV BIORESORBABLE ADHESION BARRIER
- Generic name
- Barrier, adhesion, cardiovascular
- Applicant
- Pathfinder Cell Therapy, Inc.
- Date received
- 2014-02-21
- Decision date
- 2014-04-30
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- OBD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Cambridge, MA
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