MEDTRONIC CAPSURE SP NOVUS
FDA premarket approval P850089/S041 · decided 1999-06-11
Approval details
- PMA number
- P850089
- Supplement
- S041
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC CAPSURE SP NOVUS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-05-03
- Decision date
- 1999-06-11
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for labeling changes to the Technical Specification manuals for the CapSure(R) Z Novus Model 5554 and CapSure(R) SP Novus Model 5592 pacing leads.
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