TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
FDA premarket approval P960013/S001 · decided 1998-03-19
Approval details
- PMA number
- P960013
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 1997-09-24
- Decision date
- 1998-03-19
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the use of Thermedics Tecothane T11075D-M for molded polyurethane components as a replacement for Pellethane 2363-75D. FDA also acknowledges your marketing of the Tenril DX Model 1388T/C lead, which is identical to the approved Model 1388t lead, except that it is packaged only with the clip-on tool accessory.
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