MEDTRONIC MODEL CAPSUREEPI 4695 AND CAPSUREEPI 4968
FDA premarket approval P950024/S006 · decided 2003-05-09
Approval details
- PMA number
- P950024
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODEL CAPSUREEPI 4695 AND CAPSUREEPI 4968
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2002-12-24
- Decision date
- 2003-05-09
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS.
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510(k) clearances by this applicant
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