RELAY
FDA premarket approval P910020/S025 · decided 2004-11-19
Approval details
- PMA number
- P910020
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELAY
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 2004-10-21
- Decision date
- 2004-11-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
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