TENDRIL MODEL 1488T/TC & 1688T/TC LEADS
FDA premarket approval P960013/S020 · decided 2006-06-26
Approval details
- PMA number
- P960013
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TENDRIL MODEL 1488T/TC & 1688T/TC LEADS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-05-31
- Decision date
- 2006-06-26
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGES TO THE INSPECTION PROCESS FOR MEDICAL ADHESIVE ON THE ELECTRODE RING DURING PRODUCTION OF THE LEADS.
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