PERCLOSE PROGLIDE 6 FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM
FDA premarket approval P960043/S055 · decided 2004-08-30
Approval details
- PMA number
- P960043
- Supplement
- S055
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERCLOSE PROGLIDE 6 FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2004-07-08
- Decision date
- 2004-08-30
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR REVISED INSTRUCTIONS FOR USE INTENDED TO ENHANCE THE SAFE USE OF THE DEVICES.
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