CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
FDA premarket approval P850089/S139 · decided 2018-12-17
Approval details
- PMA number
- P850089
- Supplement
- S139
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-11-21
- Decision date
- 2018-12-17
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Transfer an intermediate manufacturing step to fill Dexamethasone Sodium Phosphate and Dexamethasone Acetate into vials from Medtronic Energy and Component Center to the Medtronic Cardiac Rhythm Heart Failure Rice Creek Pharma Manufacturing Operations facility and to implement minor process improvements.
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