MODEL 7271 ICD
FDA premarket approval P980016/S001 · decided 1999-01-06
Approval details
- PMA number
- P980016
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 7271 ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1998-10-30
- Decision date
- 1999-01-06
- Days to decision
- 68 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a manufacturing site located at Medtronic, Inc., Med Rel, Road 909, KM 0.4, Barrio Mariana, Humacao, Puerto Rico, 00661.
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