CAPSURE SP NOVUS LEADS, CAPSURE SP Z LEADS, CAPSURE Z NOVUS LEAD, CAPSURE Z NOVUS LEADS, IMPULSE II LEADS
FDA premarket approval P850089/S089 · decided 2012-08-30
Approval details
- PMA number
- P850089
- Supplement
- S089
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SP NOVUS LEADS, CAPSURE SP Z LEADS, CAPSURE Z NOVUS LEAD, CAPSURE Z NOVUS LEADS, IMPULSE II LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-08-03
- Decision date
- 2012-08-30
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
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