RELIANCE/RELIANCE S
FDA premarket approval P910073/S035 · decided 2000-11-02
Approval details
- PMA number
- P910073
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIANCE/RELIANCE S
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-09-13
- Decision date
- 2000-11-02
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LUBRICIOUS COATING, REMOVAL OF ONE SUTURE SLEEVE (ON MODELS 127, 128, 147, 148), REDUCTION OF THE YOKE (ON MODELS 147, 148, 149), AND ADDITION OF THE PUERTO RICO FACILITY FOR PACKAGING, LABELING, AND STERILIZATION.
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