REPEL-CV
FDA premarket approval P070005/S002 · decided 2011-05-05
Approval details
- PMA number
- P070005
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- REPEL-CV
- Generic name
- Barrier, adhesion, cardiovascular
- Applicant
- Pathfinder Cell Therapy, Inc.
- Date received
- 2011-03-07
- Decision date
- 2011-05-05
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- OBD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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