VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD
FDA premarket approval P950022/S008 · decided 2000-04-19
Approval details
- PMA number
- P950022
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-03-20
- Decision date
- 2000-04-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Designation of alternate vendor of the silicone materials and medical adhesives used in the TVL and SPL tachycardia leads.
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