CAPSURE SP & CAPSURE Z
FDA premarket approval P850089/S056 · decided 2007-07-27
Approval details
- PMA number
- P850089
- Supplement
- S056
- Supplement type
- 30-Day Notice
- Trade name
- CAPSURE SP & CAPSURE Z
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-06-27
- Decision date
- 2007-07-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE MOLDING VENDOR FOR THE IS-1 CONNECTOR SLEEVE COMPONENT FROM MEDTRONIC PUERTO RICO OPERATIONS COMPANY TO FMI, INC.
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