MEDTRONIC. GEM DR MODEL 7271 D
FDA premarket approval P980016/S036 · decided 2003-11-17
Approval details
- PMA number
- P980016
- Supplement
- S036
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC. GEM DR MODEL 7271 D
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2003-08-22
- Decision date
- 2003-11-17
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
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