TENDRIL SDX MODEL 1488T/TC/K
FDA premarket approval P960013/S011 · decided 2003-02-25
Approval details
- PMA number
- P960013
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TENDRIL SDX MODEL 1488T/TC/K
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 2002-11-22
- Decision date
- 2003-02-25
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR TENDRIL LEAD LENGTH CHANGE.
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