CAPSURE SP NOVUS LEAD,CAPSURE Z NOVUS LEAD
FDA premarket approval P850089/S113 · decided 2015-03-02
Approval details
- PMA number
- P850089
- Supplement
- S113
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SP NOVUS LEAD,CAPSURE Z NOVUS LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-02-09
- Decision date
- 2015-03-02
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
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