MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD— 510(k) K851457
Substantially EquivalentIntermedics, Inc.
FDA 510(k) clearance K851457 for MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD, Substantially Equivalent on 1985-07-11. Applicant: Intermedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Intermedics, Inc.
- Product code
- Code DTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3620
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freeport, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.