MEDTRONIC GEM DR MODEL 7271
FDA premarket approval P980016/S020 · decided 2001-09-05
Approval details
- PMA number
- P980016
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- MEDTRONIC GEM DR MODEL 7271
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-08-06
- Decision date
- 2001-09-05
- Days to decision
- 30 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ALTERNATE MANUFACTURING AND STERILIZATION FACILITY LOCATED AT MEDTRONIC EUROPE S.A., TOLOCHENAZ, SWITZERLAND AND AN ALTERNATE PACKAGING FACILITY LOCATED AT MEDTRONIC BV, KERKRADE, THE NETHERLANDS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.