TENDRIL FAMILY OF LEADS
FDA premarket approval P960013/S029 · decided 2007-08-06
Approval details
- PMA number
- P960013
- Supplement
- S029
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TENDRIL FAMILY OF LEADS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-03-19
- Decision date
- 2007-08-06
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR AN ALTERNATE CIRCUMFERENTIAL WELD TO THE CURRENT MULTIPLE SPOT WELDS TO CONNECT THE INNER COIL TO THE HELIX SHAFT.
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