CAPSURE/CAPSURESP/NOVUS
FDA premarket approval P830061/S031 · decided 2000-01-28
Approval details
- PMA number
- P830061
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE/CAPSURESP/NOVUS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2000-01-11
- Decision date
- 2000-01-28
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- The 30-day notice requested a change in material used to manufacture the anchoring sleeves.
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