MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
FDA premarket approval P950024/S001 · decided 1998-08-12
Approval details
- PMA number
- P950024
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic, Inc.
- Date received
- 1998-04-20
- Decision date
- 1998-08-12
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc., (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
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