MEDTRONIC CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS
FDA premarket approval P850089/S035 · decided 1997-03-07
Approval details
- PMA number
- P850089
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1996-05-08
- Decision date
- 1997-03-07
- Days to decision
- 303 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE USE OF NUSIL MED-4719 AS AN ALTERNATE SILICONE INSULATOR FOR MDX4-4516
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