REPEL-CV BIORESORBABLE ADHESION BARRIER
FDA premarket approval P070005 · decided 2009-03-06
Approval details
- PMA number
- P070005
- Trade name
- REPEL-CV BIORESORBABLE ADHESION BARRIER
- Generic name
- Barrier, adhesion, cardiovascular
- Applicant
- Pathfinder Cell Therapy, Inc.
- Date received
- 2007-01-30
- Decision date
- 2009-03-06
- Days to decision
- 766 days
- Decision code
- APWD
- Product code
- OBD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR THE REPEL-CV BIORESORBABLE ADHESION BARRIER. THE DEVICE IS INDICATED FOR REDUCING THE SEVERITY OF POST-OPERATIVE CARDIAC ADHESIONS IN PEDIATRIC PATIENTS WHO ARE LIKELY TO REQUIRE REOPERATION VIA STERNOTOMY.
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