CAPUSRE SP/SENSE SP NOVUS
FDA premarket approval P830061/S037 · decided 2004-06-08
Approval details
- PMA number
- P830061
- Supplement
- S037
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPUSRE SP/SENSE SP NOVUS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2004-03-01
- Decision date
- 2004-06-08
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO MARKET THESE LEAD MODELS MANUFACTURED USING MED 2000 SILICONE ADHESIVE.
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