TENDRIL SDX
FDA premarket approval P960013/S009 · decided 2000-12-07
Approval details
- PMA number
- P960013
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TENDRIL SDX
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-11-16
- Decision date
- 2000-12-07
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE SUTURE SLEEVES USED WITH THE PACEMAKER LEADS: THE INCORPORATION OF TITANIUM DIOXIDE INTO THE SUTURE SLEEVE MATERIAL TO MAKE THE MATERIAL "MORE VISIBLE DURING IMPLANT"; INCREASING THE INNER DIAMETER OF THE SLEEVE AND; REMOVEL OF THE SLEEVE EYELET'S.
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