CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD
FDA premarket approval P850089/S093 · decided 2013-04-18
Approval details
- PMA number
- P850089
- Supplement
- S093
- Supplement type
- 30-Day Notice
- Trade name
- CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-03-20
- Decision date
- 2013-04-18
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
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