CAPSURE SP Z LEADS/VITATRON IMPULSE/EXCELLENCE S+/SS+/IMPULSE II LEADS
FDA premarket approval P850089/S077 · decided 2011-06-10
Approval details
- PMA number
- P850089
- Supplement
- S077
- Supplement type
- 30-Day Notice
- Trade name
- CAPSURE SP Z LEADS/VITATRON IMPULSE/EXCELLENCE S+/SS+/IMPULSE II LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-05-13
- Decision date
- 2011-06-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE THE CLEANING AREA OF THE DEVICES.
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